LYMEPOLICYWONK: Whose interests is the FDA protecting? Not Lyme patients, apparently
On July 31, the FDA announced it would move forward with regulations to restrict cutting edge laboratory developed tests (LDTs), which have not required FDA approval before because they are not marketed to consumers. The new regulations would change that. Why should you care?
Because LDTs include the Lyme tests manufactured by IGeneX and Advanced Laboratory Services that many patients rely on for accurate diagnosis.
The FDA’s announcement came on the heels of a July 2014 letter sent by five U.S. Senators to the budget office, urging action on the FDA’s draft guidance, which has been under review for several years. The letter specifically calls out Lyme disease testing.
“Recently, the Centers for Disease Control and Prevention (CDC) reviewed a frequently utilized LDT to detect Lyme disease and found ‘serious concerns’ about false-positive results and misdiagnosis. The CDC recommended that the diagnosis of Lyme disease should instead be left to tests approved by the FDA. [Letter here]”
I am deeply concerned that Senator Blumenthal D-CT, who supported the Connecticut antitrust action against the IDSA, is one of the five Senators who signed the letter. The other four are Sen. Edward Markey D-MA; Sen. Elizabeth Warren D-MA; Sen. Sherrod Brown D-OH; and Sen. Richard Durbin D-IL.
The FDA notice does not specifically mention Lyme disease in its proposal to regulate LDTs. However, Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health, said the regulations were in part prompted by tests that result in “unnecessary antibiotic treatments.”
What’s so bad about requiring FDA approval for Lyme tests?
The problem is that the FDA approved tests for Lyme disease are notoriously insensitive and have been shown to miss more than 50% of Lyme disease cases. (Here) Currently, the FDA has approved 84 Lyme tests, which are produced by 28 companies. [List here] Approximately 90% of these are ELISA tests, which is the first test required under the CDC two-tiered lab test recommendations for Lyme disease. However, researchers have found that the ELISA is too insensitive to be used for screening: “Our data indicated that the sensitivity and specificity of the currently used tests for Lyme disease are not adequate to meet the two-tier test approach being recommended.”
So FDA approval of Lyme tests does not equate with quality. In fact, to obtain FDA approval a lab test need only meet the low bar set by other FDA approved tests. That means if a company can afford to go through the process, it can introduce more lousy tests on the market.
Complying with FDA regulations is costly and time consuming. These regulations will squeeze out smaller companies and protect the larger companies from competition. The FDA admitted as much to the New York Times:
“The agency said the playing field was unbalanced. Some companies that have done the clinical studies to win FDA approval are competing against very similar tests that get to market without such studies and oversight.” [Article Here]
Get that? It’s not about giving patients the best care and treatment; it’s about making things “fair” for multi-billion dollar corporations that provide faulty Lyme tests. Plus, the lack of competition also means that larger companies, whose tests are already approved, will have no incentive to improve them.
The regulatory change has been widely criticized for suppressing innovation and reducing patient access to care. The American Medical Association was among the first to raise concerns, saying it believes the regulations add an additional layer of requirements which may result in patients “losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine.” The Association for Molecular Pathology (AMP) said the regulations would “harm patients by reducing access, decreasing innovation, and substantially raising the costs of essential diagnostic testing.” AMP also noted that LDPs are “often the standard-of-care, the highest quality test available, and at times, the only available testing option.”
Twenty-three laboratory directors and pathologists from academic centers including Harvard, Duke, and the University of Utah, have gone on record warning FDA regulation will stymie the growth of personalized medicine and the ability of labs to keep pace with the changing face of disease. [ARUPlab.com] The American Clinical Laboratory Association (ACLA) expressed concern about the impact on innovation and said FDA approval of LDTs is unnecessary because they have “been regulated for decades … under the Clinical Laboratory Improvement Amendments (CLIA) and by state law.” [ACLA.com] With so much heated opposition to the proposal, law firms expect “a messy fight ahead.”
The IDSA guidelines require a positive blood test to confirm the presence of Lyme. Since lousy lab tests so rarely deliver the right diagnosis, insurers rely on these IDSA guidelines to deny care and prevent patients from getting the treatments they need. (here)
Lyme patients have been railing against the poor quality of Lyme tests for years. So why aren’t better tests on the market? Blame the vested lab interests that currently control FDA Lyme testing. Among the 28 companies with FDA approved tests, at least 25% have ties to the key IDSA researchers who developed the IDSA Lyme guidelines. Drs. Gary Wormser, Raymond Dattwyler, and Allen Steere, have disclosed industry ties with at least nine companies who are involved with Lyme diagnostic tests: Biomerieux, Bio-Rad, Biopeptides, DiaSorin, Abbott, Baxter, Chembio, Immunetics, and Viramed.
A CDC study in 2008 found that over four million Lyme lab tests are performed annually at an estimated cost of $500 million. This is not chump change and in this fight, concern for patients is not even on the agenda. It’s time to recognize anti-competitive acts for what they are. The proposed regulations enrich vested lab interests at the expense of patients.
The public comment period for the proposed regulation will open in October. We hope you have your pen handy. We will keep you informed of on-going developments.
The LYME POLICY WONK blog is written by Lorraine Johnson, JD, MBA, who is the Chief Executive Officer of LymeDisease.org, formerly CALDA. Contact her at email@example.com. On Twitter, follow me @lymepolicywonk.
- August 21, 2014 at 2:58 pm
We need to get a petition started to block this. These tests are so important. Everyone needs to write to these senators.
- August 24, 2014 at 3:18 pm
Exactly. We need a petition of signatures to stop these regs. I think I will also call my congress/senate to educate them. They didn’t sign however, they do know Elizabeth Warner.
- August 21, 2014 at 3:07 pm
Would this mean, if passed, that Lyme patients could no longer receive the Igenix tests?
- August 21, 2014 at 3:24 pm
The US army patent # for lyme disease is 5,242,820.
This is simply the government doing its level best to escape culpability for this horrible, chronic disease. These five senators should be ashamed. They, as usual, are bowing to the money- not the best interests of their constituents.
- August 21, 2014 at 3:58 pm
As far as I’m concerned the CDC should be put out of business. If it wasn’t for testing from services like Igenex I would likely be a cripple by now. I had Lyme for 7 years undiagnosed because of the CDC’s poor testing. The CDC’s “approved” screening test is a waste as is it wrong 40% of the time because it is not complete. Yes, it was meant as a “screening” test to assess the presence of Lyme in large populations. But guess what? Our local hospital markets this test and tells people they don’t have Lyme when there is a very good chance they do. Who is that helping? The Western Blot is equally flawed for the same reason. If these other non FDA approved tests are not available many many people will contract chronic Lyme, another condition not recognized by the CDC. Stop the craziness. How do we inject some common sense into this process on focus on something that will help people get well.
- August 21, 2014 at 5:20 pm
All I can say is that I hope every person that places a barrier between Lyme infected persons & treatment, research, a cure, a vaccine, treatment, testing, contracts Lyme. All these organizations did the same thing w/ AIDS & waited until it became epidemic, more to the point, white heterosexual men began to get infected, to do anything. Plus, money is to be made in popular diseases such as AIDS, Parkinsons, M.S. & Lymees don’t have a popular public figure as a spokesperson. Let’s not forget how much money is made on Cancer. More people are infected w/ Lyme, each year, than AIDS & Cancer combined. If you don’t get Lyme, you will get something. Most people do & then you will be the receiver & pray KARMA does not treat you as you treat us.
- August 21, 2014 at 5:28 pm
Any U.S. citizen who has not finally realized that the whole world is being economically and politically run by a very elite group consisting of a tiny percentage–less than 1% of the world’s population, is fooling himself, or not paying attention. It would take about 5 earths to allow the whole world to live at U.S. standards. Do we have that option? No. The way to remedy that problem is to purposefully (but discreetly) eliminate those who are unnecessary (3rd World, most of the middle class, and lower class, but for the number necessary to do “the dirty work.”) We ARE living Hunger Games, but the “games” are undetected (by the average citizen), less spectacular, yet even more deadly. The state of the world’s depleted resources dictates that those with the power and money MUST eliminate “the competition;” that is “us.” Get it?
- August 21, 2014 at 5:39 pm
I am a professional woman with a Master’s Degree who asks lots of questions and thinks critically about health issues. The clear truth is that I would be dead now had I not had the very tests which these misguided Senators are trying to ban. Because those tests verified I had Lyme disease I was able to receive life saving treatment. My symptoms all responded to the Lyme treatment so the diagnosis is logically correct. You will be killing Americans, some of them children, by denying tests which are accepted in Europe. Is this pressure from the drug companies and unscrupulous doctors that benefit financially from keeping people sick and desperate? It’s the misdiagnosis of Lyme as other conditions that is the problem; not the other way around. Please view the documentary “Under Our Skin” so you can see why some ignorant medical professionals with conflicts of interest would have advised you there is a problem with the most sophisticated and sensitive testing which is often necessary to detect Lyme. I’m so deeply disappointed after having supported and been such a fan of Elizabeth Warren. I guess it’s proof that even good people can be fooled by ignorant advisors; I hope it’s not that they are being influenced by drug companies who don’t want to pay for effective Lyme treatment. This is an evil recommendation that will cause needless suffering and death and devastate families.
- August 23, 2014 at 5:13 am
I too am disappointed with the democratic senators who wrote this letter. I have contacted each one to tell them this is a harmful policy.
- August 21, 2014 at 6:35 pm
This is big trouble. Without that test to verify my very clear set of symptoms (everything else has been ruled out, including the vague dysregulation of immune response theory… thanks mainstream medicine), I’m not going to be able to pay for the treatments that have helped me recently. It seems to me that a clear cure has not yet been discovered, so they’re trying to sweep us (affordably) under the rug. I hate corporate medicine!
- August 21, 2014 at 7:12 pm
5 words: AIDS crisis all over again.
It’s obvious whoever is orchesrating all of this is protecting money and reputation, and enjoying the sociopathic power supply.
I hope they get bit by a million ticks, and rot without antibiotics, with a band playing just outside and constant sunlight, in humid Hawaii. No one needs antibiotics for Lyme Disease anyway, right?
- August 21, 2014 at 8:19 pm
When are the powers that be decide that a protection source, test. and cure is needed for the many people who have or will become Lyme patients. We suffer with the lingering effects of Lyme for many years.
A 14 year Lyme patient
- August 21, 2014 at 10:33 pm
Thanks Lorraine! This is terrible news but good to know about so we can all better intervene when public comment opens in October.
- August 22, 2014 at 3:52 am
It is sad to read what has transpired. Greed comes into play once again.
However, if there was a dependable test to confirm, the medications could begin right away, sooner recovery period. This will cut the cost tremendiously.
Guess the trees are in front of the forest.
- August 26, 2014 at 7:49 pm
Yes, if there were a dependable test and treatment there would be less of a market for a vaccine, like the one baxter has coming out.
cant have lower vaccine profits now can we.
- August 22, 2014 at 6:45 am
Please send an email to the above senators expressing your unhappiness about this situation.
- August 22, 2014 at 6:58 am
Incomprehensible, to those who are sick and are looking for a diagnoses. Until the day comes when access to thorough testing is the norm, anyone bitten by a tick should assume they have the bacteria(s) in their bodies and live as through they were treating Lyme and co-infections naturally, alternatively, organically and, other than medically. There is so much important and helpful literature available now on how to live well with Lyme and co-infections that learning how to eat, drink, play, work, sleep, cleanse, avoid, and be happy can greatly reduce and eliminate symptoms associated with Lyme.
- August 22, 2014 at 7:21 am
I expect no less from Dick Durbin, Liz Warren and friends. How wise they are in their own estimation, what heroes they are in their own eyes! Those “unecessary antibiotic treatments” have given many people their lives back you ninnies. My mother is one of them. Chronic Lyme disease is a devistating affliction. The worst part of it is the redicule you recieve from the conventional medical establishment and the lack of empathy from the community at large. We are invisable, we are going broke, experiencing severe anguish and some are dying from complications. Much more than half of Lyme diagnoses are being missed. The ones that are missed are usually the most serious and chronic cases because the patient cannot mount a proper immune defense to render a positive diagnosis!! They need to test for the presence of the bacteria and its toxins NOT an immune response, but the govt and insurance companies (which are unifying thanks to Obamacare) shoot it down every chance they get.
Not to be that guy but…Should the title be “Whose interests ARE…”
- August 22, 2014 at 7:48 am
Has anyone asked Senator Blumenthal why he is doing this? Was this the intended end result? Seems odd that a formerly supportive legislator would switch sides, when he must know about the problems with the approved lyme tests.
Some should be contacting him to find out what is going on!!!!!
- August 22, 2014 at 8:06 am
I’m not surprised, it’s political and if one is poor, old, and sick, we are doomed to be subjected to inhumane and unethical non treatment and experimentation. I can’t believe this gov made it legal. Has anyone looked at their rights lately ? or the laws themselves…this isn’t America
- August 22, 2014 at 9:06 am
Isnt there ANYONE out there that cares about Lyme patients? WHY do we have to suffer? My family has spent thousands trying to get a diagnosis that the insurance companys approve! I wish that for 1 day all of you people that either dont believe in lyme or do not want to pay for meds, a cure, or a reliable test could be in my shoes for ONE DAY! you dont care because it hasnt touched someone you care about. I guess we will have to wait until some decision maker has a family member with lyme. Then….and only then will we be heard. I cant believe money is more important then our health! Shame on you!!!!!
- August 22, 2014 at 11:03 am
I suffered with undiagnosed Cronic Lyme Disease for over 8 years before it was diagnosed correctly..if any testing should be regulated it is the Elisa test…too many false results… go to a more accurate test..Western Blot, IGeneX, stc. the more specific testing is needed…..too many people out there are sufferering from Lyme due to false Elisa testing..These darn Pharmaceutical companies and the government are controling our lives..there was a 3 stage vacine but that was taken off the US market..Heresay is that the drug companies didn’t make enough mony..what is it going to be next??
- August 22, 2014 at 12:10 pm
Even with positive tests, doctors in the mid west think it is “false positive”. People are dying and suffering needlessly. Thanks for you efforts to right this injustice.
- August 22, 2014 at 12:58 pm
Well, as my Lyme neuro-ophthalmologist had told me before on such issues…”Follow the money trail.” What don’t they want us to know? Some one or some agency has something to gain by doing this. Could it be the government was responsible for the release of Lyme bacteria from Plum Island or another facility? As a Lyme patient and a registered nurse, I cannot understand why they would do this other then for some weird gain on their part or a constituants’ behalf. I find this totally unacceptable and cannot believe they would do this. There is more concern over West Nile virus then Lyme, which we know can cause more damage and lasting effects then West Nile. We’d have better chance of receiving the right diagnosis and medical care if we had cancer. In my 44 years of nursing I have never ever expected to see something like this. For years I have wondered about the CDC and the FDA. This just confirms my beliefs of wrong doing and possibly crimes. Until someone in their families develops this terrible disease, nothing is going to change. This is so wrong. We can’t let this happen. Write to your government officials until you are blue in the face or out of ink. This kind of thing has to stop. What if they decided not to test for various cancers? I really wonder if this isn’t a potential cover up for something. The USA is to have the best health care available…I don’t believe it for a minute knowing this is possibly going to happen. Someone, somewhere is going to be making a ton of money while we suffer with the illness and don’t get the treatment we need. As a medical professional who diagnosed myself, thanks to a bull’s eye rash..my physician sent me to a psychiatrist who diagnosed me. Thanks to not being treated properly with antibiotics, I am left with multiple problems. It’s unacceptable that a nurse could not get proper treatment. Where does that put the public with any chance of getting proper treatment? Can’t wait to see where this leads and what’s behind all of this. They should be absolutely ashamed of themselves to deny treatment to those who are living with this miserable disease.
- August 22, 2014 at 1:01 pm
While I am thrilled to see the amount of money donated to ALS research (since a lot of Lyme patients develop ALS in end stage Lyme disease), you will never see that amount of money donated to Lyme Disease research. Go figure.
- August 23, 2014 at 4:16 am
I find the timing interesting, just as the under our skin sequel comes out, and spreads more awareness, and as more tests are being developed, the new culture test and the ma. acute lyme test. No coincidence.
They are using their power to protect profits not people, and it it “a shameful affair”.
- August 24, 2014 at 11:07 pm
I am stunned by the senators who signed this bill. I have been a huge supporter of Elizabeth Warren, an economist/financial expert, first term senator, who works hard for the middle class. Same for Sherrod Brown. I am writing a letter to Elizabeth. Support from the AMA should rank higher than the FDA, in my opinion. Clearly none of the 5 senators have a loved one who has been stricken with this disease. Ironic that when something affects you personally, it swings your vote a certain way. Sad, that’s all it takes. I’m greatly disappointed.
- September 9, 2014 at 3:38 am
So glad you woke up. By the way, as far as I am concerned, those Dem senators have never done anything for the middle class. They are socialists, and thus they are all about being “fair” and spreading out the goodies so the people that need help never receive it. Doing the right thing never crosses their minds.
- August 25, 2014 at 9:07 am
I recently watched a documentary about the truth on where Lyme came from. A Nazi scientist invented this for Hitler. It was used as chemical warfare to annihilate the Jewish people during the Holocaust. This scientist was hired by the U.S. soon after to spread this disease into our country. If this is true, I believe this is planned and is nothing but genocide! When will the people of the The United States of America take control of what belongs to us! I fear the present future, as we are living under socialist/communist tyrants. I honestly don’t believe writing our senators will solve this issue. There needs to be a revolution soon. I carry with me everyday a pocket sized Constitution and Amendment. This was created for the people to protect us from the government and their control! When will we wake up and reclaim our freedom America?
- August 28, 2014 at 7:34 am
IGenix saved my son’s quality of life and our family! Of course there is going to be a greater number of positives. By the time someone has gotten to the more sensitive (and expensive) testing not covered by insurance they have already been to tons of doctors and done plenty of tests. The Western Blot doesn’t even test for bands 31 and 34!
- August 28, 2014 at 2:53 pm
I do not support the current Congress to limit Lyme testing labs. That being said here’s my $0.02 on the current CDC approved test. Since the currently approved CDC Lyme test has a short 2-3 week window to “catch” Lyme, have your Dr. order a year of testing and go get tested every two weeks. And before you test do everything you can to liberate the Lyme out of your cells into your blood (exercise, sauna, fasting, massage, etc.)
I tested positive to Lab Corp’s FDA/CDC approved test but only when I was so sick I had no business driving alone 3+ hours to Detroit to see my IDSA ID Dr. (who did not treated according to IDSA guidelines); I almost cancelled that appointment but other heart tests were scheduled too and I had an Amtrak option.
My first CDC negative Lyme test was in 1995. In 2003 I tested positive on the 4th Lab Corp Lyme test drawn that year. Note when I tested positive I had exerted myself on a bicycle and a treadmill for two nuclear studies on my heart just 3 days prior and the day of the test. I’ve often wondered if that helped garner a positive test result or was it the bed ridden flu like symptoms that flared my CDC approved test positive? Since 2003 I think I’ve tested CDC positive to Lyme about 5 times and CDC negative 20+ times. I’ll tally this up and reply in October with the data.
I remember my Dr. treating me with oral antibiotics for about 8 months before I tested positive the second time. He was elated as he stated that meant he “was on the right track” and that the Lyme was becoming “unbound” in my body.
Note I’ve read, and perhaps I am living proof, that the current CDC test on the market is gender biased too as women’s bodies throw out Lyme prior to conception. I am female, age 52 now, with all of my female parts and still with menses.
I also have rheumatalogical Lyme (chronic immune mediated Lyme arthritis). I’ve heard this is the only type of Lyme CDC approved as Dr. Alan Steere that developed it used a subset of patients from his rheumatology practice to develop it.
I support one test that catches Lyme, in all of it’s types and with all of it’s manifestations, the first time tested!!
- October 23, 2014 at 10:42 am
This is just another example of the corruption of our government.Follow the money and throw these officials out of office.
- October 23, 2014 at 2:28 pm
China has told the world twice now you only ever needed one band to say pos. for spirochetal disease. And yet the severely immune suppressed can’t make that without an antibiotic challenge where the body WILL see the infections and make antibodies against them.
http://www.ncbi.nlm.nih.gov/pubmed/21112481 2010 Oct Abstract
USA MUST HAVE MISSED THE MEMO…SOOOO CHINA POSTED IT AGAIN…2013
On top of that no one never needed a pos. test, because they gave IT to us for decades in infectious vaccines. If your SICK, your SICK. Not suffering some syndrome, psych, or cancers the infections always caused.
All you as a pt. has to do is get bit by vectors carrying multiple infections so you can suffer them ALL in immune suppression of seronegative infections caused by the immune suppression you already have.
—-And if THAT was not bad enough they were also wrong about your immune status of a CD57 test. Under 100 means you are severely immune suppressed, not WELL at all like doctors are told to think. Many Lyme pts. can’t make 10 on the CD57 and should be wearing masks.
But the saddest part is the pts. suffering from the stealth recombinations who can’t get any help for the cause because of seronegative infections causing immune suppression and massive recombinations of spirochetal prion protein infections they gave us all for decades in infectious vaccines.
- October 23, 2014 at 7:42 pm
The Senators based their positions on the CDC Johnson Culture Assessment which had serious issues and was used by the CDC for the MMWR.
- November 8, 2014 at 8:30 am
Last week, I came across a very comprehensive essay on the CDC’s critique of the Sapi paper on the Borrelia culture and I want to share the link to the essay.
In its critique, the CDC claimed that the one of the set of PCR results in the Sapi paper demonstrated that Advanced Laboratories Borrelia culture was contaminated and was giving false positives. This claim by the CDC was used over and over again by those who are recommending FDA approval for all tests for Lyme disease, including Senator Blumenthal’s in his letter to the FDA.
Unfortunately and mysteriously, the essay is anonymous. Even so, the material presented is a very thorough and scholarly analysis of the Sapi paper and I can’t find anything suspicious or questionable about it. The blog analysis also closely corresponds with the major points that was given by Dr. Joseph Burrascano in his presentation on the ALS culture at this years ILADS conference. I didn’t go to the ILADS conference, but I have a copy Burrascano’s Powerpoint presentation.
A short summary of the essay – The CDC paper omitted relevant data and their conclusion that the culture was contaminated is erroneous. Evidence from the negative controls, monoclonal and polyclonal antibody testing, and one set of the PCR results (DNA sequencing) demonstrate that the cultures were not contaminated with the European strain B. garinii or B. afzelli. It is possible that one of the set of sample taken from the culture and processed for PCR analysis was contaminated after being taken from the culture, but this does not negate the rest of the experiment or the culture itself.
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