Razzle
Frequent Contributor (1K+ posts)
Member # 30398
posted
The FDA wants to regulate customized (non-standardized) medical tests as devices, meaning specialized tests developed for Lyme testing (amongst many other conditions) would become extremely expensive or unavailable at all.
Please take action on this and save our Lyme tests!
-------------------- -Razzle Lyme IgM IGeneX Pos. 18+++, 23-25+, 30++, 31+, 34++, 39 IND, 83-93 IND; IgG IGeneX Neg. 30+, 39 IND; Mayo/CDC Pos. IgM 23+, 39+; IgG Mayo/CDC Neg. band 41+; Bart. (clinical dx; Fry Labs neg. for all coinfections), sx >30 yrs. Posts: 4166 | From WA | Registered: Feb 2011
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Catgirl
Frequent Contributor (5K+ posts)
Member # 31149
posted
Razzle, thank you for posting this!
Everyone, this will affect you! Please sign this!
-------------------- --Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together). Posts: 5418 | From earth | Registered: Mar 2011
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posted
From the above linked article: --- "The FDA has wrestled with the question of how to regulate LDTs for many years. The agency developed a draft guidance on how they plan to increase regulation of LDTs, but it has been stalled in the Office of Management and Budget (OMB) since 2010. Currently, the FDA employs enforcement discretion to regulate LDTs because they are considered low-risk.
Now a group of senators, Ed Markey (D-MA), Elizabeth Warren (D-MA), Richard Blumenthal (D-CT), Sherrod Brown (D-OH), and natural health’s old nemesis, Dick Durbin (D-IL), wrote to OMB asking that the LDT draft guidance be released.
The senators’ letter specifically cites Lyme disease as an example of “false positive results and misdiagnosis” and asserts that the “diagnosis of Lyme disease should instead be left to tests approved by the FDA.” It also implies that LDTs should undergo premarket review.
What is at the bottom of this push for regulation? And why are the senators so concerned about Lyme disease?
Special interests (and, given our crony capitalist approach to everything, the government) want regulation because there are LDTs they don’t want to pay for, or they fear the diagnosis will lead to treatment expense! Lyme disease is a prime example, as we’ve noted in the past."
Posts: 14 | From Ashland, Oregon, US | Registered: Nov 2013
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posted
Done
Posts: 123 | From Washington State | Registered: Dec 2013
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Abxnomore
Frequent Contributor (5K+ posts)
Member # 18936
posted
Done.
Posts: 5191 | From Lyme Zone | Registered: Jan 2009
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Catgirl
Frequent Contributor (5K+ posts)
Member # 31149
posted
We need more people to sign this! Thank you everyone who has signed it.
-------------------- --Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together). Posts: 5418 | From earth | Registered: Mar 2011
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Catgirl
Frequent Contributor (5K+ posts)
Member # 31149
posted
I know people don't feel well enough to get involved with stuff on a regular basis, but this is so serious!
Come on Lymenet members! You just fill it out click and send (real easy)!
-------------------- --Keep an open mind about everything. Also, remember to visit ACTIVISM (we can change things together). Posts: 5418 | From earth | Registered: Mar 2011
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posted
Thank you Richard for speaking out for Lyme patients. Please show interest in this very important topic by sharing and commenting on this letter.
KarlaL
Wall Street Journal
LETTERS Leave Well Enough Alone on Lyme The Democrats don't offer credible arguments for why Lyme disease diagnostics should be strictly regulated.
Aug. 13, 2014 4:49 p.m. ET Regarding the article "FDA Seeks to Regulate Lab-Developed Tests," (Marketplace, Aug. 1): The five Democratic politicians petitioning the Office of Management and Budget don't offer credible arguments for why Lyme disease diagnostics should be strictly regulated.
Increasing regulations for Lyme disease diagnostics will remove treatment choices from patients and doctors. The current Food and Drug Administration-approved, two-tier testing is inaccurate and was intended for the Centers for Disease Control's surveillance purposes, not diagnostics. In fact, "approved" tests screen for only one strain of the bacteria that cause Lyme disease, Borrelia burgdorferi, and there are dozens of strains that cause harm to human beings. It's no wonder so many false negatives exist.
The CDC acknowledges 300,000 new cases of Lyme disease each year in the U.S., and 15%-20% of treated patients suffer ongoing severe pain, fatigue, cardiac, neurologic and arthritic illness. False negative results lead to tens of thousands of misdiagnosed patients each year.
Legislators should focus their efforts on increasing funding for research to improve Lyme disease diagnostics, not increasing regulation that will reduce innovation and limit access to better quality tests.
posted
Excellent opinion piece from Lorraine Johnson on why Lyme patients should be very concerned about giving the FDA control over all Lyme disease testing. Please spread the word by sharing this piece.
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? . . .
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