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DanSharpIBD's profile
Dan Sharp
Dan Sharp
Dan Sharp
@DanSharpIBD

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Dan Sharp

@DanSharpIBD

Patient advocate | Medical Laboratory Scientist🔬 (ASCP) | #DisruptiveInnovator | Interests include cats, stats, & evidence-based medicine | #IBD

DanSharpIBD.org
Joined December 2014

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    Dan Sharp‏ @DanSharpIBD 3 Jun 2019

    Dan Sharp Retweeted John Fauber

    This is sensationalism and not journalism. @fauber_mjs, @journalsentinel, and @USATODAY should be ashamed. Their report is likely to needlessly scare a lot of people about biologics, so I'd like to offer some context/info, starting with the FDA adverse event reporting system.https://twitter.com/fauber_mjs/status/1134085613400076288 …

    Dan Sharp added,

    John Fauber @fauber_mjs
    Safety issues with biologic drugs used to treat autoimmune diseases have grown to the point that they now are linked to more than 500,000 serious adverse events, including 34,000 deaths, in the last 15 years. Here is our first story: https://tinyurl.com/y6ygp5f5  @kcrowebasspro
    8:45 PM - 3 Jun 2019
    • 28 Retweets
    • 64 Likes
    • Matt Woo Brian - The Spoonie Ironman Zach Wallace Mygiddyaunt Zachary Borman MD Ethan Craig Ben Peter Higgins Sciurine
    9 replies 28 retweets 64 likes
      1. New conversation
      2. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        The author claims "the FDA defines an adverse event as any undesirable experience associated with a medical product." Very misleading. The FDA defines adverse events (AEs) as "any symptom that occurs while taking a drug". https://fis.fda.gov/extensions/fpdwidgets/2e01da82-13fe-40e0-8c38-4da505737e36.html …pic.twitter.com/6wEleylkmu

        1 reply 2 retweets 10 likes
        Show this thread
      3. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        This means adverse events can include *anything* that occurs while a person is taking a medication. For ex: • It can be a symptom of the disease being treated. • It can be nausea from food-poisoning. • It can be pain from a gunshot wound (obviously unrelated to any biologic).pic.twitter.com/aB9zt5JCVG

        1 reply 2 retweets 10 likes
        Show this thread
      4. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        If a causal link was even *suspected*, it would be reported as an adverse drug reaction (ADR) aka "side effect". However, even for an ADR report, no causal link can be established. Yet, the article & headline are designed to make the reader think biologics caused 34,000 deaths.pic.twitter.com/h4rEgSd2BA

        1 reply 2 retweets 9 likes
        Show this thread
      5. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        The FDA itself will tell you that you should not interpret a report of death to mean the treatment caused it. ANY death while on treatment can be reported, no matter what the actual cause was. "34,000 deaths" is bullshit.pic.twitter.com/YjxJKDbOUv

        FDA FAERS reports - how to interpret death reports.
        1 reply 2 retweets 12 likes
        Show this thread
      6. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        AEs can be reported by healthcare professionals, drug manufacturers, and patients themselves. The reports are not verified, they are just recorded. Duplicate entries often exist because patients may report the same event as their doctor. No causal links can be made in any case.

        1 reply 1 retweet 8 likes
        Show this thread
      7. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        While patients/clinicians can voluntarily submit AE reports, it is mandated that any symptoms/events that occur during clinical studies be reported. It doesn't matter if there's essentially no chance the drug was the cause.https://www.fda.gov/safety/reporting-serious-problems-fda/reporting-health-professionals …

        1 reply 0 retweets 8 likes
        Show this thread
      8. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        Should the FDA's adverse event reporting system be used to determine the safety profile of drugs? Once again, according to the FDA: NO.pic.twitter.com/mknQB5Zlcq

        1 reply 0 retweets 6 likes
        Show this thread
      9. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        Now, as I don't want to take up too much time on this piece, I'm going to point out a few issues that demonstrate, I believe, the disingenuous and/or lazy nature of the reporting.

        1 reply 0 retweets 7 likes
        Show this thread
      10. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        The story of Helen Tschannen's histoplasmosis is sad. However, this is wrong: "Tschannen, it turns out, was at special risk of a bad infection, not because of her age or because she lived in a region where the fungus lurks, but because of a drug she had started taking[...]"pic.twitter.com/oH4kG3Rq7Q

        1 reply 0 retweets 6 likes
        Show this thread
      11. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        There are known risk factors for serious histoplasmosis infection. In particular: • Age > 55 yrs • Location • Suppressed immune system https://www.cdc.gov/fungal/diseases/histoplasmosis/risk-prevention.html …pic.twitter.com/Hxi02AAZ8z

        1 reply 0 retweets 6 likes
        Show this thread
      12. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        Helen had all three risk factors. Helen was at increased risk of severe histoplasmosis due to age (77), where she lived (southern IL, an endemic region), and the medications she was taking (several other unnamed medications for Rheumatoid Arthritis in addition to the biologic).pic.twitter.com/MLSCZiB8cV

        County-specific histoplasmosis incidence (no. cases/100,000 population)
        Histoplasmosis outbreak locations
        Areas endemic for histoplasmosis
        1 reply 0 retweets 5 likes
        Show this thread
      13. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        Histoplasmosis is a known concern for those on anti-TNF therapies, as well as any drugs that can suppress immune system. It's been studied a lot, particularly since 2004 when Helen died. But according to the article, she wasn't treated for histo as it apparently wasn't suspected!

        1 reply 0 retweets 6 likes
        Show this thread
      14. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        There are multiple instances where the author *could* mention absolute risks or otherwise provide some context, but apparently chose not to. Remicade is mentioned as having the "highest rate of infections among several biologic drugs". Sounds scary without knowing true risk.pic.twitter.com/v4xWIKb2NA

        1 reply 0 retweets 6 likes
        Show this thread
      15. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        While anti-TNFa use is associated with increased histoplasmosis risk, the incidence is still very very low. For instance, infliximab (Remicade) incidence is estimated at 18.78 per 100,000 people, and etanercept (Enbrel) at 2.65 per 100,000 people.https://www.ncbi.nlm.nih.gov/pubmed/19634920 

        1 reply 0 retweets 7 likes
        Show this thread
      16. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        While awareness and increased vigilance are good, fear-mongering is not necessary. Diagnosis and treatment guidelines are available from the Infectious Disease Society of America, and include information on patients taking anti-TNF biologics.https://www.ncbi.nlm.nih.gov/pubmed/17806045 

        1 reply 0 retweets 6 likes
        Show this thread
      17. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        This is absurd misinformation: The author claims the FDA approval system "allows drug trials that may last a year or even less". Either the author didn't bother to check or he's being disingenuous...pic.twitter.com/QtqtV3jHEs

        FDA trials misinformation
        1 reply 0 retweets 6 likes
        Show this thread
      18. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        Phase 1-3 of the clinical trial process take ~8+ years on avg for biologics. Even the abbreviated biosimilars path involves ~5+ years of clinicals trials. And all this does not even include post-marketing studies & other steps of drug development process. https://www.jmcp.org/doi/full/10.18553/jmcp.2017.23.12.1234 …pic.twitter.com/AuqO5kyq7U

        1 reply 0 retweets 5 likes
        Show this thread
      19. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        There are risks with *any* medical treatment. There are also many serious risks when autoimmune/immune-mediated disease are not treated properly. This article can *only* misinform patients who are trying to make treatment decisions with their physicians.

        2 replies 2 retweets 13 likes
        Show this thread
      20. Dan Sharp‏ @DanSharpIBD 3 Jun 2019

        There are many studies demonstrating the positive benefits of biologic use in these diseases. I may continue this later with more information on biologics, and possibly more information on how bad this article is. But, I'm leaving it for now as I'm sick of looking at it.

        2 replies 1 retweet 13 likes
        Show this thread
      21. Dan Sharp‏ @DanSharpIBD 4 Jun 2019

        If you had any doubts that this piece is sensationalism designed to scare & generate clicks/attention, this tweet from @journalsentinel should make it clear. Appalling. Again, the "34,000 deaths" claim is BS based on misuse of data from FDA's adverse event reporting system.pic.twitter.com/ctAUghXayl

        1 reply 0 retweets 7 likes
        Show this thread
      22. Dan Sharp‏ @DanSharpIBD 4 Jun 2019

        The author repeatedly mentions the cost of biologics, which seems to add nothing to the story. However, it makes sense given this false analysis was funded by @NIHCMfoundation, whose board is all insurance company execs. This is a hit piece on drugs they don't want to cover.pic.twitter.com/Zloh6lrF77

        3 replies 2 retweets 20 likes
        Show this thread
      23. End of conversation

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