EMSL lab director acknowledges EPA investigation; offers free repeat ERMI

PUBLIC SERVICE ANNOUNCEMENT

I was asked to share this information.  Apparently there is a problem with EMSL’s Environmental Relative Moldiness Index (ERMI) and people are being offered a free do-over.  Seems that it has been marketed to the mold community though various websites and people need to know how to obtain their free do-overs — so they are not living with a false sense of security as to the safety of their living and working environments.

Two key highlights from Dr. Shoemaker’s message that he asked me to share:

“Just to be clear: I am stating my opinion that anyone, including Dave Asprey and his employee who is selling ERMI from EMSL, as well as any and all others promoting flawed ERMI testing, should stop now and refund all users since 6/22/2015, at least until EMSL and all other labs with quality control problems pass all aspects of EPA quality control. The public trust depends on lots of sunshine being focused regarding this important question about validity.”

“Beginning in late spring 2015, physicians from the Professionals Panel of Surviving Mold noted that something was odd with a variety of Environmental Relative Moldiness Index (ERMI) reports. A number of labs, including EMSL, appeared to not report low levels of Aspergillus penicilloides, A. versicolor and Wallemia sebi. ERMI testing (involves MSQPCR DNA identification and quantification) is a necessary part of a peer reviewed, published protocol used to diagnose and treat chronic inflammatory response syndrome (CIRS) caused by exposure to the interior environment of water-damaged buildings (WDB). Significant health risks are associated with low levels of these fungi when present in WDB, with as few as 10 spore equivalents/mg dust markedly associated with acquisition of illness.”

The message in its entirety:

“EMSL lab director acknowledges EPA investigation; offers free repeat ERMI

Beginning in late spring 2015, physicians from the Professionals Panel of Surviving Mold noted that something was odd with a variety of Environmental Relative Moldiness Index (ERMI) reports. A number of labs, including EMSL, appeared to not report low levels of Aspergillus penicilloides, A. versicolor and Wallemia sebi. ERMI testing (involves MSQPCR DNA identification and quantification) is a necessary part of a peer reviewed, published protocol used to diagnose and treat chronic inflammatory response syndrome (CIRS) caused by exposure to the interior environment of water-damaged buildings (WDB).   Significant health risks are associated with low levels of these fungi when present in WDB, with as few as 10 spore equivalents/mg dust markedly associated with acquisition of illness.

Many people think that Stachybotrys is the important fungus in damp buildings (“Black Mold; Toxic Mold”), and it is but to a very small extent, but the Aspergillus species named above are major players in occurrence of adverse health effects caused by exposure to the interior of WDB.

Another under-stated organism, Wallemia sebi, also was under-reported by EMSL in casual physician observations. Far more important, Wallemia likes lower water activity (A(w)) than other fungi (and bacteria!) in wet buildings. Wallemia is perhaps the worst actor of all the molds when it comes to risks for acquisition of human illness from WDB. From its drier locations, especially in ductwork, Wallemia gets no significant publicity on the Internet but it sure does in offices of actual data-driven, CIRS-treating physicians.

Simply stated: EMSL wasn’t finding the DNA of these organisms often.   Even worse, other mycology labs found these DNA markers in the same places when EMSL didn’t. Was there a problem with methods used by EMSL? If so, was the problem in primers (ABI but not IDT?), probes or TaqMan enzymes? Or the DNA analyzer?

We reported our concerns to experts at the EPA who promised to initiate an investigation. And they did.

Remember that the patent for QPCR testing for ERMI was granted to the EPA in 5/14/2002, number 6,387,652 B1. EPA began licensing their testing protocols to private labs later, provided that the testing outlined in the EPA Standard Procedures for Fungal DNA QPCR Analysis was followed.

Think about it, here we have EMSL, a reputable lab, having problems detecting low levels of important organisms, but for most of the newbies (they seem to be appearing faster than wire grass in a new garden!) coming to the mold field, who would ever know? Add to the problem of rookies trying to help mold patients is the entry of another entrant into the ERMI field, myERMI. When this outfit, linked to Dave Asprey and his new Bulletproof Internet business, announced they were providing ERMI testing, they asked, any questions?

Even now, you can hear my voice on the (listen to it on the Bulletproof website) trailer for Dave’s movie, Moldy. So, Dave knows me.

I asked who their ERMI lab supplier was. Answer: EMSL. What were the primers EMSL used? I was surprised at the aggressive non-response from Dave’s employee.

“What do you want that information for? What relevance is the primer?” Whoa, bro! Just answer the question.

You know, when someone is not responsive to a simple question, they usually are doing so for some no-good reason. Attorneys really focus on non-responsive answers. Me too. I still have a lot more questions for this non-responder. We expect politicians to be evasive, not salesmen. Moving on.

Actually, all DNA labs obsess over accuracy of MSQPCR testing, the basis of ERMI. All DNA labs must pay attention to much more than primers, but primers are where the analysis is based. They must be exquisitely careful with a series of lab methods. Primers, enzymes and machines all are important in providing people in a life and death situation with accurate information. Imagine if someone with CIRS-WDB were told that a building was assuredly safe because the ERMI was low and then the patient went into the building with a false sense of security. What would happen to the victimized patient? We all know.

There would be a significant relapse, with all its chronic proteomic and genomic abnormalities. Who would be responsible for the ensuing wrongful death or disability? The lab? Or the agent that funneled business to the lab when they must have known, or should have known, the lab was having trouble?

Now imagine being the business outfit that sells ERMI. Do you think that ongoing EPA investigation for failure to meet specifications from patents and lab procedures might fit into your advertising campaign?

Can you understand how people like me would be demanding accuracy from labs? And can you understand why I would be demanding accuracy from outfits like myERMI who seemingly didn’t know what a primer was, yet was selling ERMI tests? Maybe it is just my opinion, but if I am selling a test, I feel I have to know everything a reasonable person would be expected to know about that test.

Just to be clear: I am stating my opinion that anyone, including Dave Asprey and his employee who is selling ERMI from EMSL, as well as any and all others promoting flawed ERMI testing, should stop now and refund all users since 6/22/2015, at least until EMSL and all other labs with quality control problems pass all aspects of EPA quality control. The public trust depends on lots of sunshine being focused regarding this important question about validity.

But how did anyone know that EMSL was having problems with their assay? Quality control is supposed to be performed with every new batch of chemicals used in such a complex assay. No one demands publication of the results of QC, however. The EPA can’t force its ERMI licensees to do anything! But a question still nags at me: if the lab isn’t following dictates of both the patent and lab instructions, can we really say the lab is using the patented test?

By the time myERMI was selling EMSL testing, the investigation of EMSL procedures and results was already initiated. One can only wonder how a lab test that was being doubted by a Federal agency was being sold by a non-medical website without informing the public of the investigation. Didn’t they know that they might be selling a test that could get them in trouble? Sounds to me like old fashioned due diligence was missing.

So I called EMSL, asking about problems with the EPA testing. Dr. Charlie Li was direct with me on the phone on 9/23/2015. He knew there was a problem. He was working with EPA to resolve the difficulty with “non-detects.” He promised me that everyone who had an EMSL ERMI done in the last three months could be repeated at no charge when the methods of EMSL were corrected. Just call the EMSL phone number on your lab result, ask for the lab, give them the lab number on the upper right hand corner and ask the lab to repeat the test at no charge when the lab passes EPA requirements.

I hope that everyone who had an EMSL ERMI done since 6/22/2015 will contact EMSL or their test broker to obtain a repeat of their ERMI when the lab is doing better in QC for the three species of incredible importance. If the ERMI was sold through a broker, I feel a refund is in order.

Are there people harmed by the difficulty EMSL has? I don’t know. But my data set is truncated at best. At www.survivingmold.com we are willing to be a clearing house for information regarding possible adverse health effects from flawed ERMI reporting. Alternatively, if you have concerns, perhaps if your ERMI was bought from and paid to myERMI you could contact myERMI, as all of their ERMI reports done since they started their service in mid-July will likely be flawed. Dave Asprey has written me that he wants to help people get better; so let him make things right. I don’t speak for Dave but since he wants to help people by offering ERMI testing, and I believe that he will stand by his products, let him obtain your refund for you.

When I raised the issue of quality problems with EMSL with Dave on our call 9/9/2015 at 12:30 EDT, he wasn’t receptive, yet promised to look into the matter, which he did. Two weeks later, Dave and his employee apparently didn’t feel that they had to know the science underlying the product they were selling. Hypothetically, when anyone is selling unsubstantiated treatment with some diet or another to mold patients using environmental studies that are being investigated, how can one say diet is the culprit when the environment is falsely being ruled out? Remember, saying one feels “amazing” as a testimonial doesn’t translate to showing data to a journal editor and unbiased reviewers.

If you think you have been injured by a falsely low reported ERMI from EMSL from 6/22/2015-9/22/2015, please don’t go seeking a lawyer. Let us know and we will help you. No charge.

There are so many points to be made with this lab problem. I remember doing cardiac isoenzymes in Clinical Chemistry years ago. If my CPK result showed heart attack, that person was changed forever. Integrity of science and medicine was my mantra then. Still is. Medical care for CIRS is not just a game or a profit-making venture. Integrity counts.

I remember well fifteen years when the outspoken voices of mold world were Jonathan Wright, Erik Johnson, Sharon Kramer and me, with maybe a few others. Internet sales? Nope. Weren’t there. Now 15 years later, mold is selling like crazy. Crazy is a good word for the unsupported claims. If today’s Internet is a “Wild, Wild West,” patients surely can be swayed by slick advertising, just like they might be at a used car lot. In mold venues, if you are selling, sell truth. Sell honesty. For patients, if the claims of Dr. Mike O. Toxin (made up name) aren’t matched by high quality, published peer reviewed data, skip using your credit card that day.

Now, you should see the non-existent data and undisciplined ideas about mold being sold that are dressed up like the Emperor (the one with no clothes).   “Yes, I ate this food and I got sick. I know it was the food because I never lie and I don’t need science,” says one. Another says, “Ignore what you eat, your urine shows what is wrong with you.”Another is now selling “special nutrients;” and others are selling “methylation correctors.”The list goes on.

OK, let us see the data. Oops. None are available. Our group has been publishing for 15 years! You want data? So do I. We have published data on over 2500 adults and children in peer reviewed literature, not to mention 1000 controls and two double blinded, placebo controlled clinical trials.

I still am bemused by folks thinking that diet will cause CIRS-WDB illness (Oh, really?), knowing that this attempt at an argument was one we defeated in fierce one-on-one combat in mold litigation. When the CDC says diet is no big deal (MMWR 2/2015), and they do (and the overwhelming scientific community agrees), don’t start buying mold free tea or mold free wheat or mold free blue cheese or mold free mushrooms. Dietary causes of CIRS-WDB illness? Show me some science. Show me objective markers in a prospective study.

The world of CIRS-WDB is now full of tests providing objective fingerprints of brain injury, proteomics and genomics. We are in a Golden Era of peer reviewed, published papers on therapy of CIRS-WDB. We must demand scientific integrity from our new-found Internet sales machines. We cannot giveaway our science for false hopes based on marketing ploys.

Thankfully, EMSL has said they have a problem with their ERMI results. The EPA is working with them and other labs to make sure we won’t have the problem of possibly unreliable ERMI results in the future. Let us all revisit their ERMI products in the future when the bugs are out of their systems. Talk to Dave Asprey; I’m sure he will get your money back if you bought a flawed ERMI from him.”

As we all know by now, the mold issue is complex and mistakes get made by relying upon the words and actions of others — who may also be relying upon the words and actions of others.  The true test of character is when one takes action to acknowledge the mistake and moves to correct any problems it may be causing.

Thank goodness that this one looks relatively easy to correct any possible damage done, by people simply being made aware of the problem and being provided an opportunity to accept help to undo it.  Glad to see EMSL is offering free do-overs of ERMI.  Hopefully, others will follow suit.

Sharon Kramer

PS. Don’t contact me if you have any questions.  This is not my area of expertise in the mold issue.  I’m simply forwarding a public service announcement.

Contact Dr. Shoemaker with any questions.  He says,

“If you think you have been injured by a falsely low reported ERMI from EMSL from 6/22/2015-9/22/2015, please don’t go seeking a lawyer. Let us know and we will help you. No charge.”

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One Response to EMSL lab director acknowledges EPA investigation; offers free repeat ERMI

  1. sharonkramer says:

    Received the below message from a highly respected microbiologist in this issue:

    “Sharon,

    Commercially available Realtime PCR developed by EPA and related ERMI should not be used at all. There are issues in addition to what is indicated in your email.

    Attached is an EPA IG’s report on ERMI. [ http://freepdfhosting.com/82bb173e73.pdf ]

    Most probes and primers for the fungi on EPA’s list are not species specific. They are mostly based on outdated taxonomy.

    Best,
    XXXX”

    I have no opinion one way or the other on the merits or downfalls of ERMI usage. I have not taken the time to research and educate myself on this part of the mold issue to form an opinion about ERMI. Its not relevant to what I do in this issue.

    Am simply relaying the infomred opinions of others who I trust, and I know have worked for years to help mold victims. Sometimes opinions, even among the most trusted, may differ with each other and be based upon their perspectives of what they do in this issue and how they use certain tools.

    If I were one who was inclined to use ERMI, I would want a better understanding of what this info that I am publicly relaying, means as it relates to my situation.

    Sharon

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