Survey: FDA Proposed Regulation of Lyme Tests

General or non-medical topics with information and discussion related to Lyme disease and other tick-borne diseases.
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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Sat 15 Nov 2014 18:49

Duncan wrote:

It is saying there are people who have made decisions, and those who continue to make decisions today, that are leaving GROTESQUELY HIGH NUMBERS OF PEOPLE SICK with TBD's to fend for themselves.
From RR:
Lyme disease sufferers protest at Infectious Diseases conference
Oct. 11, 2014

About 75 PEOPLE PROTESTED outside the Pennsylvania Convention Center on Saturday, urging mainstream physicians and federal health officials to broaden their approach toward diagnosing and treating Lyme disease.

[Where were all those thousands and thousands of chronic Lyme patients?]

Among the protesters was Joshua Cutler, of Winchester, Va., who says he has chronic Lyme disease. Cutler says he had a thriving career as a network engineer for the federal government in 2006 when he suddenly fell ill. After a series of false starts, Cutler found a doctor who he said correctly diagnosed chronic Lyme disease. He began a treatment plan that has made his condition marginally better, he said.

[He found a quack who made him feel “marginally better” and probably financially poorer.]

Relations at the IDSA meeting with the Lyme disease protesters were testy. Cutler and several others were ejected when they tried to gain access to an IDSA dinner Friday night.

[Well, he obviously feels well enough to cause trouble, organize a protest, and run a web site.]

Like Cutler, the protesters all told heart-wrenching stories of dealing with disease symptoms for years after conventional treatments had failed. They have lost homes, spent down 401ks, and endured great physical hardship.

[Yet, they have enough time and money to travel to Philly, check into hotels, and stand around on the street bothering people.]

Because they say traditional medicine has let them down, Cutler and others have turned to what they call "Lyme literate" physicians who dispense with the official protocols and offer treatments such as high-dose intravenous antibiotics.

[There is no “traditional medicine”. There is just medicine, and whatever voo-doo the quacks practice.]

The response of conventional medicine to the chronic Lyme movement has been unyielding, and in some instances acerbic. Dr. Paul Offit, an infectious disease specialist at Children's Hospital of Philadelphia - and co-inventor of rotavirus vaccine - in his book "Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine" describes physicians who offer alternative Lyme treatments as quacks out to make a buck.

Science seems to be on his side. In his book, Offit remarks that four separate studies of long-term antibiotic therapy, using one group of patients who receive medication and another who received only a placebo, there was no discernible difference in disease outcomes. He also faults physicians who promote alternative cures for claiming that the Lyme bacteria is able to "hide" in the body, and thus not respond to short-term treatment.

"The claim by Lyme literate doctors that bacteria are hiding out of sight of researchers (despite appropriate antibiotics) is akin to the claim by Bigfoot literate people that only they know the monster exists," Offit writes.

Dr. Stephen Calderwood, president-elect of the IDSA and chief of the infectious disease unit at Massachusetts General Hospital in Boston, said he is convinced that many people who have suffered from Lyme have persistent symptoms. What is unknown is the cause. It is entirely possible that ongoing symptoms are the result of an immunologic response, long after the Lyme bacteria is gone.

Like rheumatic fever, whose aftereffects include damaged heart tissue long after the bacteria is gone, there may be similar aftereffects from Lyme, Calderwood said. "We are all desperate to find out what works and make people feel better," he said.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Sat 15 Nov 2014 19:44

Wait, let me see if I understand these bracketed observations correctly: First he sarcastically wonders why there aren't very many chronic Lyme sufferers protesting, THEN he wonders aloud that there are any actually able to show and check into hotels, etc?

Logic at its finest. ;)

If there are at least 300,000 identified cases of Lyme per year, how many of those are refractory to treatment? More importantly, how many are there that go undiagnosed and in whom the disease progresses to Late Stage, i.e. a stage that even the IDSA admits is more difficult to treat and resolve?

After you estimate those numbers, multiply that figure by, say, 20 or 30 or 40 to represent the number of years that population has been building.

Whatever number you come up with will likely be on the low end. Worse still, it will only represent Late Stage numbers in the United States, and will exclude our neighbors to the north and south, and in Europe and Asia and the rest of the world.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Sun 16 Nov 2014 13:56

I have a question...

If Dr. Linda Bockenstedt found dead left-over immune-reactive pieces of Lyme spirochetes in the cartilage of mice after they were treated with antibiotics, why is Dr. Steere now saying that our post-treatment symptoms are due to some auto-immune dysfunction?

Isn't the immune system working to remove this left-over debris? How can that count as auto-immune? The immune system cells are attacking foreign bodies, they are reacting to "not-self" bacterial antigens.

Wouldn't Linda Bockenstedt's finding preclude Steere's theory?

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Sun 16 Nov 2014 14:01

Nnecker, hv808ct, and Rel-Risk -

I can tell you where I was during the protest.

Can you guess?

That's right! I was right here. Stuck in bed. Just like I am most of the time. I'm gonna take a guess that that's where all the other people too sick to go to a protest were.

So you can all go to hell.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by nnecker » Sun 16 Nov 2014 16:14

Here is a White House petition for Lyme: ... itstart/10

They needed 25,000 signatures in thirty days to get the petition to move on to the next step.At the end of the thirty days,they got around 10,000 and the petition expired because it failed to meet the signature threshold.I would bet that a good portion of those signatures were from friends and relatives who don't have Lyme.

In desperation this was posted,"IMPORTANT..CHILDREN 13 AND ABOVE CAN SIGN THIS! circulate fast! LAST DAY!"

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by Lorima » Sun 16 Nov 2014 17:03

On a whim, I tracked down the actual source of the article that nnecker quoted above. I took a rare trip to the Rel-risk blog and found it there, including the bracketed comments, but with no attribution. It sounds professionally written, not like RR's voice. So I searched for a word sequence that should be unique, "Offit wrote that in four separate studies", including the quotation marks.

Here's the byline and a link to the original article:
POSTED: Sunday, October 12, 2014, 1:09 AM

Read more at ... SCmphXJ.99

It's kind of interesting to see what RR included, and what he snipped. Not sure why he doesn't link, or at least attribute his long quotes; copyright issues?

I was going to make some comments on Offit's extending his punditry to LD, but decided it was too far off topic.
"I have to understand the world, you see."
Richard Feynman

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Sun 16 Nov 2014 17:39

Oh that nnecker, he's such a "scoundrel".

He seems to take some sort of delight in what he considers as shortcomings of a Lyme advocacy's efforts at the federal level. What an odd thing to revel in, the efforts of sick people to get better treatment falling short.

What he fails to mention, maybe because it doesn't sit well with his sense of mirth, is an undeniable trend that benefits Lyme advocates. Within the US, State by State, almost inexorably, legislature is emerging to give clinicians more freedom to treat as they see fit, and to even warn patients of the inherent limitations and risks associated with current diagnostics, e.g., too many false negatives.

Meanwhile, more and more patients are stepping forward to lend testimony (in the media, in front of Congress, and more) to the travesty that defines patient treatment all too frequently. More and more, researchers unfettered by party line are stepping up - sometimes unilaterally, sometimes in groups - to dig deeper into the Science, to move the bar forward, as opposed to holding it back. Lewis, Zhang, Baumgarth, Clark, etc, their numbers continue to mount. Momentum has been slow to grow, but it is growing. Also, the greed of some of the chief culprits is coming back to haunt them; in order to promote new tests, to grow their markets, this group must demonstrate a need for the new tests, and it seems that sometimes the way they've gone about accomplishing that goal is by denigrating existing tests like the ELISA and Western Blot. They must cannibalize the reputation of their flagship products to push new products into new markets. Their credibility is bit by bit crumbling in the process, only I suspect they are too self-absorbed to realize it.

It cannot happen too soon, but the pendulum is slowly swinging away from the grasp of that strange relatively small group from which Lyme doctrine has historically emerged. All those patient anecdotes are forming patterns of data, patterns that defy outdated myths promulgated by the few at the expense of far too many. It's these patterns that contrast with the biased and subpar research from much of the past. It's patterns such as these that help underscore the indifference to the suffering of citizens that I feel characterizes much of the prevailing policies.

It is these and other patterns, coming increasingly into the public's view, which eventually will bring down this house of cards. At the same time, new sources of exciting Science are springing up, and their findings also often run counterpoint to the boilerplate spewed out for the last 30 years. hv808ct spoke of conspiracies. Here's one he can take home: New TBD facts are conspiring to undo the harm we've been forced to endure for decades.

It's just a function of time. Tick tock.
Last edited by duncan on Sun 16 Nov 2014 20:31, edited 2 times in total.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by duncan » Sun 16 Nov 2014 19:00

As a little aside, I cannot help but wonder if the reason organizations like the NIH are not drilling down on salient characteristics that would help differentiate between Late Stage Borrelia and all its manifestation, from PTLDS and all its manifestations, is simply they are fearful that a profile match might be the end result in a significant portion of the two supposedly distinct populations.

Lyme tests from new independent sources could help cast light on that possibility.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by RitaA » Sun 16 Nov 2014 23:46

Lorima wrote: Sorry if all this contradicts anyone's naive faith in the purity of science and modern medicine (or conversely, seems like belaboring the obvious). It's not comfortable; just how it is, as nearly as I can discern. Certainly, I had no idea medical science was so corruptible, 10 years ago. I can't blame people for initially being shocked and disbelieving, when they encounter a long-term, unfixable mess like this, propagated by the most trusted institutions. For people who center their belief system on science and technological progress, the shock must be almost existential. On the other hand, I do have to wonder about all the seemingly intelligent people who are excessively slow to recognize what's gone on here, and what it implies about the fragility of (at least medical) science, even when they've personally encountered all the pieces of the puzzle, and spent time thinking about it. Could it simply be that we're reluctant to give up a modern version of religious faith?
In "Cure Unkown: Inside the Lyme Epidemic" (on page 372 of the paperback version of the first edition), Pamela Weintraub wrote:
The political struggle over Lyme disease is likely to rage for years, but it is ultimately science, not politics, that will rule the day.
While reading her book, I was really hoping to come across some practical and realistic suggestions/solutions for resolving the current mess associated with Lyme disease. I'm not sure that I did, although I did finish the book with a sense that science will prevail even if it takes many more years or even decades.

That said, MS was identified over a century ago, and some would argue that we aren't much closer to understanding exactly what causes it or even how to treat it effectively in some cases. Since there are subtypes of MS (and cancer, for that matter), this probably shouldn't come as a big surprise to anyone.

Will it take a century or even half a century to completely answer any outstanding questions, and to resolve any outstanding issues related to tick-borne diseases? I'm guessing that it might. Is there a way to speed up the process? Barring a complete overhaul to the way medicine is practiced and medical research is conducted, I suspect there isn't. Hopefully I'm wrong on both counts.

So, to answer your question: "Could it simply be that we're reluctant to give up a modern version of religious faith?"

Yes, I do believe that the vast majority of people are reluctant to give up their belief that science holds the answers, and that most medical research is conducted by people with integrity -- despite human beings and the current system being far from perfect. To give up that belief/faith might mean questioning a whole lot more about our lives, and that could potentially become even more uncomfortable for many people.

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Re: Survey: FDA Proposed Regulation of Lyme Tests

Post by velvetmagnetta » Mon 17 Nov 2014 10:45

We seem to have gotten way off-topic in this thread. This original post was about the new proposed regulations the FDA wishes to impose on in vitro laboratory developed tests (IVDs) This is a test that is conceived, developed, administered, and then analyzed all in one lab.

I'm not sure why this particular criteria is so important. So, if a company uses more than one lab to accomplish all of this, its tests are subject to less regulation?

I really do like the idea of a company being required to show evidence that its tests really do what they advertise. Yet, this legislation seems particularly aimed at the many varied tests offered for Lyme disease, specifically. This legislation, though, would be more far-reaching than just affecting Lyme disease tests.

Are they sure they want to limit all tests in this way? Or is the FDA really just trying to regulate Lyme tests? We need to be careful here - if we're just trying to fulfill a vendetta against a philosophy of one particular disease, or do we want this kind of strict legislation requirement for all lab tests everywhere?

Doesn't this new criteria also exclude the 2-tiered WB/ELISA tests as well? There is not sufficient evidence that these tests can diagnose Lyme disease (as it still warns right on your copy of the test results).

It's kind of funny that in their zeal to rid the world of all other interpretations of Lyme, they have excluded their very own tests!

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