Recalls and Congressional Hearings

I was getting ready to post an article on insomnia, which will be forthcoming shortly, when I got sidetracked by watching a portion of congressional hearings focusing on the automaker Toyota. Anyone who has been watching the news lately has to have heard by now that Toyota is in the cross hairs of congressional hearings in Washington, D.C.  Toyota has come under public scrutiny due to alleged defects in some of their automotive models.  Toyota is recalling millions of autos in hopes to correct possible acceleration defects that, according to the latest facts I could find, have been linked to a possible 275 crashes and 18 deaths over the past 11 years.  I agree that these deaths are tragic and warrant the company to investigate and correct and malfunctions, but let is put this in perspective with our fluoroquinolone plight.

According to Medwatch, the adverse drug reporting arm of the FDA, the following statistics are available on fluoroquinolone antibiotics, from a period from 1997 to 2007: Levaquin 39,128 adverse drug reactions (ADR’S) and 808 deaths, Floxin 13,495 ADR’s and 311 deaths, Cipro 40,395 ADR’s and 837 deaths, Avelox 30,160 ADR’s and 337 deaths, and Proquin 40,151 ADR’s and 831 deaths.  For this list of FQs, and it is not a total inclusive list, the total adverse drugs reactions are 163,329 with deaths totaling 3,124. According to the FDA, reports to Medwatch only represent between 1% and 10% of the actual numbers of occurrence.  Why?  The FDA states that most people have never heard of the Medwatch program and a lot of doctors are not inclined to waste their valuable time in reporting adverse drug reactions or telling patients about it.  Looking at the facts from the FDA’s own admission, deaths from FQ’s could easily total over 30,000, based on if only 10% of the actual occurrences have been reported.

Now humor me for a minute as my logical mind kicks in.  Toyota recalls millions of cars and has to appear before congressional hearings because of the possibility that a defect cause 275 crashes and 18 deaths over 11 years, and the fluoroquinolones antibiotics have caused, at the very least, 163,329 ADR’s and 3,124 deaths, and no hearings, no outcry, no acknowledgement from the medical community? Why?  These drugs have caused untold suffering to thousands and could possibly be implicated in the cause or exacerbation of many other health disorders, which is a topic for another article.

Now one may try to argue back that hundreds of thousands of prescriptions have been given out for fluoroquinolones and they have an excellent safety record.  Compared to what?  Millions of Toyota’s have been sold and now have come under scrutiny for 275 crashes and 18 deaths.  Don’t you think that 3,124 deaths (when the actual figure could be as much as 30,000) warrant more scrutiny? What will it take to get stronger wording and cautions for other damages other than tendon injuries? Patients need to be informed that the use of these drugs for other than life saving necessity can results in a host of severe reactions, which can cripple for an extended period.

In American today it is unfathomable to me that a group of people so large, can fall into a hole, and, despite the evidence, their pleas for help go unheeded.  I know that many in FQ community have tried for years to get the attention of the medical community and law makers.  Despite failures, we must continue to fight, anyway we can, and build upon the small successes to overcome the resistance.

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Admin

...damaged by fluoroquinolones in 2007 at age 46. Prior to, a healthy law enforcement official. Now an amateur FQ researcher, author, and blogger.

9 Responses

  1. John Fratti says:

    David,

    Very nice article about recalls and congressional hearings. That article really put things in perspective. Great analogy and comparison. Keep up all the good work that you do on this blog.

    Best,
    John

  2. L G Lindsay says:

    Great essay! Your insight should raise eyebrows in many quarters including Congressional hearings into quinolone toxicity syndrome (QTS) and into what steps the FDA is taking to mitigate the risk or supply unwary consumers and their doctors with additional warnings. Pls continue the high calibre of your postings!

  3. Katie B says:

    Well said! I am forwarding this one to lotsa people.

  4. John says:

    Great post – this really puts into perspective where our leaders’ priorities are!

  5. Kotaki says:

    I like your blog

  6. Mondor says:

    would it be possible to translate your website into spanish because i have difficulties of speaking to english, i would like to read more of what you are writting .

  7. Janice Wever says:

    Nice post. Just found it on Bing. tks for the useful info. Keep up the great work 🙂

  8. Alan J. Redd says:

    Very well reasoned post.

    There was one scientific study that compared the safety record of flouroquinolones directly to other antibiotics:

    Averse drug reactions related to use of fluoroquinolone antimicrobials: an analysis of spontaneous reports and fluroquinolone consumption data from three Italian regions. Leone Roberto et al. 2003. Drug Safety 26:109-120.

    This study included 10,011 adverse reports (any drug). 22.5% of the ADRs involved fluoroquinolones.

    “The overall incidence of adverse events associated with fluoroquinolone use in the US and Europe varies widely among different fluoroquinolones, from 4.2% for ofloxacin to 47% for grepafloxacin. Information concerning the grue incidence of adverse drug reactions (ADRs) can not be obtained by spontaneous reporting, since the events are always under-reported. However, when consumption data are available, comparing the toxicity profiles of drugs in the same therapeutic class and with similar indications that are marketed in the same country in a comparable period of time is generally acceptable because under these conditions, the under-reporting can be assumed to be more or less of the same magnitude for the reference drugs.”

    “….the percentages of reactions involving the central nervous system (12.2 [quinolones] vs 3.6% [other systemic antimicrobials]), musculoskeletal (14.7 vs 0.3%) and psychiatric (9.3% vs 1.8%) were significantly higher (p <0.01). "

    So you see when compared directly to alternatives, the fluoroquinolones have a very poor record.

    Best wishes,
    Alan

  9. acudoc says:

    H.L. Mencken: “No one is safe as long as Congress is in session.”

    Don’t you just wish that Congressmen would go out and get real jobs? Toyota is a GREAT company which has done the world far more good than the 80,000+ pages in the Federal Registry! These blowhards in the House and Senate (with the exception of ONE man, Ron Paul) are an embarrassment ot the very concept of intelligence.

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