CDC

CDC Kaiser Update

The CDC Investigation page on “Unexplained Dermopathy” (Morgellons) was updated on Nov 1, the relevant changes were:

old:

As part of CDC’s ongoing process to identify potential sites for the epidemiologic investigation, in July 2007 CDC published a solicitation notice about CDC’s planned investigation of this unexplained dermopathy in Federal Business Opportunities. In the notice, CDC announced that it may award a contract to Kaiser Permanente Northern California to assist the government in conducting the investigation. The notice also served to solicit the services of other organizations that may be capable of doing tasks related to the investigation, as specified in the notice. CDC will award a contract to the vendor that is identified during the solicitation process.

new

To learn more about this condition, the CDC is conducting an epidemiologic investigation. The CDC has awarded a contract to Kaiser Permanente in Northern California to assist the CDC in the investigation of this condition. The investigation will begin after review and approval of the scientific protocol by the CDC and the Kaiser Permanente institutional review boards (IRBs). IRBs have an important role in the protection of the rights and welfare of all research participants.

old:

When does CDC plan to begin the investigation?

The investigation will begin once the contract is awarded to the vendor that is selected. CDC will begin work with the qualified vendor immediately to identify and evaluate patients who are eligible to participate in the planned investigation

new:

When does CDC plan to begin the investigation?

The investigation will begin after review and approval of the scientific protocol by the CDC and the Kaiser Permanente institutional review boards (IRBs). IRBs have an important role in the protection of the rights and welfare of all research participants.

So, as expected, Kaiser was awarded the contract (there were no other possible candidates, based on the FBO specification). However the interesting news is that BOTH the CDC and Kaiser still have to sign off on IRB approval of the scientific protocol. IRB Clearance was originally scheduled for October 30th. I doubt this means much besides laggardness, but I’d be very interested in hearing just how they are going to organize a patient cohort of “persons who have reported themselves as having this unexplained skin condition” without any additional criteria.

CDC vs. OSU

The CDC today released a “Request for Quotations” for their Morgellons investigation, which is basically a formality, as the only entity they would qualify to do the work is Kaiser. They also listed the lab tests that would be done (basically all the standard systemic tests).

http://www.fbo.gov/spg/HHS/CDCP/PGOA/Reference%2DNumber%2D2007%2DMorgellons/Attachments.html

They give a list of the work to be done:

2.1. Describe the clinical and epidemiologic features of persons who have reported themselves as having this unexplained skin condition, including assessing the frequency of co-morbid conditions (e.g., neurocognitive deficits, neurologic conditions, major psychiatric disorders).
2.2. Collect information to generate hypotheses about possible risk factors for this condition.
2.3. Assess the histopathologic features of the skin condition based on skin biopsies from a sample of affected patients.
2.4. Characterize fibers or threads obtained from patients with the condition to determine their potential etiology.
2.5. Describe the geographic distribution and estimate rates of illness.
2.6. Describe health care utilization among persons with the condition.

And a timeline:

4.1. IRB [Independent Review Board] Clearance October 30, 2007
4.2. Database of potential cases (study cohort) November 30, 2007
4.3. Database containing all results of clinical evaluations, Including recorded histories and physicals, laboratory tests (See Attachment 001 for required laboratory tests), chest x-rays, digital photos, neuorcognitive/neuropsychiatric examinations. March 1, 2008
4.4. All skin biopsy specimens and fiber samples collected from case-patients . March 1, 2008
4.5. Electronic database containing demographic information, zip code of residence, relevant past health history, such as medications, provider visits, and hospitalizations for cases. Database should include a unique patient identifier to allow linkage of clinical and other test results with demographic, healthcare utilization, and survey data. April 30, 2008
4.6. Database with denominators for all visits (total and by specialty) and hospitalizations during study period to allow estimation of disease rates in the population. May 30, 2008

That’s exactly what you should do if there is some evidence of a new infectious disease, parasite or environmental contamination. You get a patient population (the “study cohort”), and you investigate their symptoms, and see what they have in common, and look for common risk factors and diagnostic markers that might indicate a cause.

What’s a bit unusual here is that the patient population is “persons who have reported themselves as having this unexplained skin condition”, in other words: “people who think they have Morgellons”. This entire study is simply of people who THINK they have Morgellons. Very interesting.

The CDC are investigating Morgellons because it is an “emerging public health problem” and they have “received an increased number of inquiries from the public, health care providers, public health officials, Congress, and the media“, and “some who suffer from this condition appear to have substantial morbidity and social dysfunction, which can include decreased work productivity or job loss, total disability, familial estrangement, divorce, loss of child custody, home abandonment, and suicidal ideation“. All true, but with contested causation.

But wait a moment, why is the CDC getting ready to spend millions of dollars investigating Morgellons, when they simply could go to Oklahoma State University, where:
http://www.healthsciences.okstate.edu/morgellons/vision.cfm

OSU-CHS physicians/researchers have physical evidence of Morgellons Disease
– Morgellons is not psychiatric in origin
– Morgellons is an emergent disease

No only that, but they already have a patient population all of which can be instantly diagnosed by the appearance of fibers under the skin.
http://www.healthsciences.okstate.edu/morgellons/docs/Wymore-position-statement-2-19-07.pdf

Of the thirty or so patients claiming to have Morgellons disease, that clinical faculty have examined in facilities associated with OSU, only one patient likely did not have Morgellons.

100% of the patients, that were felt to genuinely have Morgellons Disease, have large microscopic-to small macroscopic fibers visible under their outer layer of skin.

There are doctors and professors there who have been looking at this for years, and have sufficient evidence to convince themselves 100%:
http://www.mysanantonio.com/news/medical/stories/MYSA072406.morgellons.KENS.1e13fade.html

“I am 100 percent convinced that Morgellons is a real disease pathology,” said Dr. Randy Wymore, an assistant professor of pharmacology and physiology at OSU.

Dr. Rhonda Casey has examined more than 30 Morgellons patients.
“There’s no question in my mind that it’s a real disease,” she said.

So if Oklahoma State University has already figured this out, why don’t they help out the CDC? Do they actually have any evidence? Could it be they’ve been a little hasty in their certainty? Perhaps a little unscientific? Or could they save the CDC some money?

CDC – Federal Business Opportunity to Study Morgellons

http://www.fbo.gov/servlet/Documents/R/1771563

The Centers for Disease Control and Prevention (CDC), Coordinating Center for Infectious Diseases (CCID), National Center for Zoonotic, Vectorborne, and Enteric Diseases (NCZVED), Division of Parasitic Diseases is seeking to award a sole source commercial contract for investigation in California of an unexplained dermopathy (Skin Condition) which some refer to as Morgellons.

The Government has determined that Kaiser Permanente (KP), Northern California is the only responsible source to meet the Government’s needs. Morgellons is a rare condition with a heavy concentration in California, and KP is the only organization that has the location, coverage area, and membership size to provide the large sample size required for the study. Minimum managed care organization membership required to satisfy this study is 25% of the population in the region selected. Other minimum vendor qualifications for this requirement are: electronic health records that have been implemented in the organization at least since January 2006; ability to conduct electronic queries of medical records, including progress notes, to identify clinical conditions and complaints; health maintenance organization with at least 3 million enrollees and coverage of at least 25% of the population in the chosen geographic area; location in a geographic area with a large number of suspected cases; experience in conducting clinical and epidemiologic studies; adequate qualified personnel to successfully perform the requested services by the date required.

The proposed effort will involve the following: describing the clinical and epidemiologic features of persons who have reported themselves as having this unexplained skin condition, including assessing the frequency of co-morbid conditions (e.g., neurocognitive deficits, neurologic conditions, major psychiatric disorders); collecting information to generate hypotheses about possible risk factors for this condition; collecting skin biopsies to assess the histopathologic features of the skin condition ; obtaining fibers or threads from patients with the condition to determine their potential etiology; describing the geographic distribution of this condition; estimating rates of illness in the population; and describing health care utilization among persons with the condition.

Total period of performance will be seven (9) months from date of award. The Government intends to issue a Request for Quotation (RFQ) on 31 July 2007, with award anticipated by 31 August 2007. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

Well, I guess we’ll just have to wait until March (or May?) 2008 for the results. It certainly will be very interesting though.

CDC: Unexplained Dermopathy (Morgellons)

The CDC has been talking about looking into “Morgellons” for a while, and I’ve been surprised they never mentioned it on their web site, despite having a phone line set up to take Morgellons related messages. Well, they finally put up a page.

http://www.cdc.gov/unexplaineddermopathy/

It lists the symptoms of Morgellons, and says:

The etiology of this condition is unknown, and the medical community has insufficient information to determine whether persons who identify themselves as having this condition have a common cause for their symptoms or share common risk factors.

This is exactly what I’ve been saying all along. There is no evidence that Morgellons is a distinct disease. There is no evidence (insufficient information) that people who say they have Morgellons have anything in common other than their symptoms. There is no evidence of a single cause.

They also say something else I’ve always been saying:

Persons who believe they may suffer from this condition should contact a healthcare provider for evaluation and medical care.

Morgellons is currently a list of symptoms. A very long list of symptoms that can be caused by a very large number of conditions. Sure, you can “have Morgellons”, but that just means you have some of the symptoms. It does not mean you have the same thing that other Morgellons believers have.

The CDC is saying that, since there is no evidence of a common cause for this set of symptoms called Morgellons, if you have some of these symptoms, then you should go to a healthcare provider, so they can try to determine the actual causes of your symptoms, and fix them, or at least treat your symptoms.

On the title of the CDC page: “Unexplained Dermopathy” – that particular phrase was created just for Morgellons, it produced zero Google hits up until yesterday. “Dermopathy” is a disease of the skin. When a disease is “unexplained”, it is often referred to as being “idiopathic“. A very large number of skin conditions and symptoms are idiopathic. For example, Erythema Multiforme is a disease with many symptoms very similar to Morgellons (lesions, itching, malaise, joint pain and vision problems), yet 50% of the cases of EM are idiopathic. So “Unexplained Dermopathy” is really not a very good name for a distinct disease. On the other hand, it’s a good name for a large collection of unexplained cases of various dermatological symptoms.