Patients Become Advocates for Next Generation Sequencing - 30,000+ Sign Petition
Medical Establishment Sabatoges Fight Against Chronic Infections (Part 4)
The Patients
While even the American Urological Association Guidelines state the patients in the cited study had “better improvement in their symptoms,” the guideline avoids even a weak recommendation of molecular testing as a supplementary measure when traditional cultures fail.
The guidelines raise, again, the possibility of physicians confusing non-disease-causing bacteria with pathogens and the further possibility this may lead to the over-prescription of antibiotics. What the authors fail to consider or even pursue are a doctor’s options when traditional cultures fail as they so often do. Their underlying premise seems to be that the “empirical method”—doctors guessing at what antibiotics should be used in the absence of knowledge—must be preferable to knowing all the bacteria and fungi present in a specimen.
Why?
According to the microbiology expert, Dr. Michael Schmidt, there have never been any studies addressing best practices in antibiotic stewardship. (The only data available come from recent studies clearly indicating molecular testing’s superiority as to antibiotic stewardship.) The authors of the guidelines are, by default, recommending current practice, for no other reason than it is current practice. They have no data as to its utility in the very things about which they claim to be worried: diagnostic confusion and antibiotic stewardship.
This becomes painfully apparent when patients’ experiences are examined.
A health activist, Carrie Anne, started a petition on March 6, 2023, on Change.org asking physicians to use MicroGenDX as a second diagnostic tool in UTI cases where traditional cultures fail. To date, more than 30,000 people have signed this petition.
Carrie Anne’s work echoes that of Melissa Kramer, who in April of 2016 founded LiveUTIfree.com.
CUTIC (Chronic Urinary Tract Infection Campaign) advocates on behalf of recurrent UTI sufferers out of the United Kingdom.
Seven million women are diagnosed with UTIs each year in the United States alone and as many as 44% of these recur within a year. Melissa Kramer recounts her experience which motivated her to found LiveUTIFree:” “When I look back at my experience with recurrent urinary tract infections, I have flashbacks of traumatic moments followed by lingering anxiety about when the next one would hit me…. Was it possible to overcome constant UTIs and yeast infections? It took me around five years to find out that yes, I could.”
Carrie Anne’s story began in July of 2022 when she came down with a UTI. A single mom, she had spent 20 years raising her two girls, serving as a Girl Scout Troop leader, and a yoga instructor, while slowly, slowly finishing her bachelor’s degree. She had just completed that milestone when she contracted her infection. She had experienced a similar infection eight years before and did not think much of it, as it passed quickly. She tried home remedies first, drinking lots of water, cranberry juice, and taking the over-the-counter AZO products.
When the infection did not go away, she saw her primary care physician. He took a urine specimen and put her on antibiotics right away, before seeing the results—a common practice. She took them exactly as prescribed; did not miss a beat. Unfortunately, the medication provided no relief whatsoever. During a vacation to celebrate her birthday, her symptoms worsened so much that she went to the local hospital’s Emergency Room. There she received a prescription for a different antibiotic.
The second antibiotic failed, and she returned to her primary care doctor. He took another specimen, which came back negative. “You don’t have an infection according to this,” he told her. She had already been on two different antibiotics. Her physician admitted he did not know what to do. Strangely, he failed to refer her to a urologist.
Lacking any useful answers, she tried “holistic” cures, reflexology, and acupuncture. These measures supplied no relief.
She returned to the primary care physician hoping for better luck, and this time he diagnosed Bacterial Vaginosis (BV): a condition that happens when there is too much of certain bacteria in the vagina. He wrote a prescription for a third antibiotic to address the BV.
Carrie Anne didn’t even bother to take this. She knew her body well enough to know her condition had nothing to do with her vagina.
She found another primary care physician but had to wait two months before she could be seen. In the interim, she began visiting an Urgent Care facility, and ended up going eight or nine times over the next four to five months. The facility had a Physician’s Assistant who actually listened to her. That was a welcome change. The PA also referred her to a urologist, whom she saw in October, after the infection had been raging for more than three months.
The urologist took a specimen. When they met again, the urologist reported that according to the urinalysis Carrie Anne did not have an infection. (After the rounds of antibiotics Carrie Anne had taken there was no chance anything would grow in a petri dish, which the urologist plainly should have known.) The doctor diagnosed her with Overactive Bladder and gave her medication for that condition. She should take it for the next two to three months and see how she felt. This only exacerbated her infection because it slowed the pace of evacuating her bladder and allowed the bacteria there to thrive even more.
She visited the urologist’s office two more times as the overactive bladder medication failed to provide any relief. They kept running traditional cultures, which time and again proved negative. The doctor sympathized with her symptoms, knowing how painful a UTI could be, she said, but sent her on her way without providing any additional care.
On one visit, Carrie Anne brought in a case study she had found examining other bacteria that could be the cause of her infection. The doctor took one look at it, and said, dismissively, “Oh no, that [bacteria] is supposed to be there.”
At the end of her third visit, the urologist referred her to another urologist who was a two-hour drive away in a neighboring city.
She saw the second urologist in January, after her infection had been present for six months. There, she was administered a MicroGenDX test. The test revealed that she had a very high load of the bacteria, Klebsiella, not E.coli, as her other physicians had speculated: the more common cause of UTIs. There were three other species of bacteria identified as well, which had formed a fiercely strong polymicrobial community or biofilm. She was prescribed another round of antibiotics, this time targeting the strongest of the bacteria, Klebsiella.
The many types of antibiotics prescribed were targeted to a type (or types) of bacteria, but, unfortunately, no combination of antibiotics had been positioned to attack the different bacteria of her polymicrobial infection simultaneously. This would be key in finally resolving her condition. If Carrie Anne’s doctor had taken the time for a private consultation with a MicroGenDX expert—a free service offered to physicians—the test could have been used far more effectively, as Carrie Anne would eventually discover for herself.
Throughout this ordeal Carrie Anne found among the physicians with whom she worked an outward sympathy that only masked an underlying indifference. Of course, doctors need to be dispassionate and objective as possible in assessing a patient’s condition, as Carrie Anne understood.
She told the physician she “didn’t even want to be here anymore. I’m on the verge of wanting to end my life.” When she later reviewed the doctor’s notes about their visit, the doctor recorded that the patient described her symptoms as “bothersome.” That a doctor—a woman—could translate “debilitating” into “bothersome” blew Carrie Anne’s mind.
Even though the pathogen had been correctly identified for the first time, the antibiotics prescribed failed. Two additional rounds of antibiotics did as well. Her physician did not try to attack the different strains of her polymicrobial infection simultaneously, unfortunately, which would prove to be key in finally resolving her condition.
On her third visit in March, the second urologist decided to refer her to an Infectious Disease specialist. She had concluded that Carrie Anne’s condition had “nothing to do with her bladder.”
While waiting to see the Infectious Disease specialist, Carrie Anne found out about Hiprex from online community health groups. Not an antibiotic, Hiprex makes the bladder so acidic that it inhibits the growth of bacteria. (Dr. Alan Wolfe, whom we met in Part 3, believes it may operate in another way, but acidity is the prevailing theory.) The Infectious Disease specialist was willing to prescribe this for her, which was the first thing that brought a measure of relief. Carrie Anne was able to return to something like her normal life.
She went back to her urologist and asked why Hiprex hadn’t been prescribed. The doctor kept insisting that she did not have an infection, despite the efficacy of the Hiprex, despite the findings of molecular testing.
Twice more, Carrie Anne had a MicroGenDX test run. Each time it came back with the same four bacteria, with Klebsiella by far the dominant strain. The doctor then prescribed another antibiotic, Amoxicillin. Carrie Anne knew that the MicroGenDX test indicated that the bacteria present had resistant genes to Amoxicillin, and asked her physician why she prescribed it anyway. The doctor admitted she had ignored the findings of the MicroGenDX test as to amoxicillin. One physician in the practice commented: “Oh, well, we can't trust that test. Because it reads all types of bacteria. You can’t say that's the one causing your infection.”
Carrie Anne finally stumbled, mostly by herself, into a solution that physicians who use MicroGen employ regularly. The Klebsiella needed to be targeted, but so did the other bacteria in the biofilm. As in Robert Taylor’s case with which this report began, the various bacteria needed to be targeted simultaneously. (This is especially true after an infection has been growing for a long period of time.)
She took another MicroGenDX test, and compared her antibiotic prescriptions to date with those noted on the test to which there would be no antibiotic resistance. The only role she wanted her urologists to play at this point was to prescribe the antibiotics MicroGenDX suggested as potentially helpful. She went to her urologist and asked for one prescription and went to the PA at Urgent Care and asked for a second type. Along with her Hiprex, she took both newly prescribed antibiotics together. Since then, she’s been feeling much better. She now lives mostly UTI free.
Carrie Anne still has flare ups, though. The longer an infection goes without effective treatment, the more likely its recurrence. The bugs are smart. That’s why prompt and accurate diagnoses and treatments are so important.
Reviewing Carrie Anne’s experience, the expert urologist Dr. Timothy Hlavinka comments: “Based on Carrie Anne's and many, many other patients' anecdotes, the human suffering has been immense, and an embarrassment to the profession. That does not include the financial costs of out of pocket, copays, out of network charges, labs, doctor visits and medication costs, among others. It is a powerful tool that needs to be mainstreamed in medicine yesterday.”
Through other online communities and her petition, Carrie Anne has discovered she is far from alone. Sampling the comments section of the petition, one finds haunting echoes of Carrie Anne’s experience over and over again.
One writer comments: “I have dealt with an embedded UTI for a year and [it] has caused damage to my pudendal nerve. Even if I get cured of the infection, I may always deal with this crippling condition that has taken away my nursing career and my life. We need better testing. We need more of a voice. People all over the world are suffering.”
Another: “I am currently accessing MicroGenDX as a Canadian patient because of months of pain & symptoms that persist after an infection that are not showing up on culture. It is a shame that we are not using the most modern methods & tech available in the healthcare industry, which could change lives.”
Another says simply: “I lost my mother to an undiagnosed UTI that resulted in sepsis.”
In the light of these patients’ experiences and tens of thousands more like them, the idea that prescribing antibiotics in the absence of knowledge is the best means of antibiotic stewardship can only be considered grotesque. Carrie Anne went through 25 rounds of antibiotics before finally hitting on a combination, by virtue of paying attention to her molecular testing, that brought about a substantial remediation of her condition, if not an outright cure.
Her frustration with the care she received and the desire to help others avoid a similar struggle led both to her petition and her writing personally to the CEO of Aetna Insurance, Karen Lynch. She reasoned that as a woman Karen Lynch might well have contracted a UTI or must know many women who had. Carrie Anne summarized her story for Ms. Lynch. Then she asked why Aetna did not cover the cost of testing, as it would help prevent the immense suffering alluded to by Dr. Hlavinka and even save the insurance carrier money.
She received a response from Zuri C. of the Executive Response Team. Zuri C. recommended Carrie Anne consult the following link from Aetna’s Clinical Policy Bulletin, noting that the MicroGenDX test (along with competitors like Karius and Johns Hopkins Metagenomic next generation sequencing for central nervous system (CNS) infections) remained characterized as Experimental/Investigational. Zuri C. goes on to lecture: “the human body is colonized with ~39 trillion microbial cells, most of which do not have clinical significance, so how to interpret the test is often unclear, without evidence to show the test improves outcomes, and with the risk that over-prescribing of antibiotics is likely. The research itself indicates, ‘outcome studies are needed if there is to be widespread adoption of NGS.’”
As we showed in our section on current research, many outcome studies have now been published and an abundance of clinical experience clearly indicates that MicroGenDX’s molecular testing promotes antibiotic stewardship. We wanted to know if Aetna and other major medical insurers are now aware of this.
Insurance Companies Stonewall Inquiries
We wrote to representatives of Aetna and Cigna and the national office of BlueCross/Blue Shield, major medical insurers who refuse to cover MicroGenDX testing. (Earlier we noted that BlueCross/BlueShield does cover MicroGenDX testing in a handful of states. It does not do so in California, New York, and many other states, however.)
After sharing a summary of Carrie Anne’s experience and the response she received, we asked a series of questions. With these emails we included a bibliography of outcome-based studies and cited the PLA code given by CMS to MicroGenDX as evidence that molecular testing should no longer be considered “experimental/investigational,” but should be covered by all medical insurers.
Our questions included the following:
1. When traditional culture is negative and the patient still has clear signs and markers of infection, what is your company’s guidance to the treating physician? What is the basis for this guidance?
2. Given the failure rate of traditional testing to identify and treat many common recurring infections and the poor antibiotic stewardship this failure encourages (such as Carrie Anne’s UTI and 25 rounds of antibiotics) has your company evaluated the role of testing accuracy in encouraging better antibiotic stewardship by physicians?
3. In making determinations of reimbursement policy for clinical lab testing, insurance experts frequently cite the need for outcome-based studies. Have those responsible for your policy considered the attached outcome-based studies? If these studies have yet to be considered by your policy committee, will they be reviewed and when?
4. While each insurer has a right to determine the scope of its coverage, are you aware that Medicare and Medicaid both cover MicroGenDX's testing? Medicare granted MicroGenDX its own PLA code - 0112U in October of 2019. Under Medicare regulations, a basic requirement for finding a diagnostic test to be medically reasonable and necessary is that the treating physician has to order it to help manage the patient.
5. Finally, has your company ever conducted longitudinal cost/benefit analyses to determine the true cost of chronic infections such as UTI's? The information I have been able to gather to date indicates that such policy decisions are made by panels of experts without reference to longitudinal data studies. Is this true?
To date Aetna, Cigna, and the central office of BlueCross/BlueShield have failed to respond.
These major insurance companies’ refusal of coverage may be seen as a cost-saving measure. This “cost-saver” may backfire, however. Carrie Anne and others are considering bringing a class action lawsuit against the major health insurers for withholding approval of coverage for MicroGenDX and other providers of molecular testing. The nearly 30,000 signatories of Carrie Anne’s petition constitute a significant class, representing millions more who deserve the best possible care. Stonewalling won’t work forever.
When will the “promise for the future” of molecular testing finally arrive, though? And how? We will take a look at that in our final article in this series.
This special report is sponsored by MicroGenDX.