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Medicine Businesses

Unsealed Emails Show How J&J Shaped Report On Talc's Links To Cancer (bloomberg.com) 88

An anonymous reader quotes a report from Bloomberg: Unsealed emails reveal the role baby-powder maker Johnson & Johnson played in a report that an industry group submitted to U.S. regulators deciding whether to keep warnings off talc-based products linked to cancer. The emails -- unsealed in the state of Mississippi's lawsuit against J&J over its refusal to add a safety warning -- show J&J and its talc supplier chose the scientists hired by their trade association, the Personal Care Products Council, to write the 2009 report assessing talc-based powders' health risks. They also show the researchers changed the final version of their report at the companies' behest. The U.S. Food and Drug Administration said it relied in part on the report in its decision to forgo a warning for the product.

The emails among executives of J&J and Rio Tinto Minerals, its supplier at the time, provide a behind-the-scenes glimpse of dealings between companies and their industry group that successfully fended off a cancer warning on talc-based powders for nearly 40 years. Now, almost 39,000 users and their families are suing J&J, most claiming their ovarian cancers and those of loved ones were linked to asbestos, the potent carcinogen in the products pulled from U.S. and Canadian shelves in May 2020. Dependence on industry data creates a situation that's ripe for lobbyists to exert pressure on the FDA. The unsealed emails pull back the curtain on how such efforts get launched, who pays for them, and who has a hand in delivering the final product to regulators.

While the practice of companies having a say in industry group submissions to the FDA isn't new or illegal, the emails reveal just how involved J&J got in a report meant to assess product safety -- down to selecting individual scientists to produce it and having them write an executive summary. J&J denied any wrongdoing in its decision not to acknowledge its input to the report that the PCPC lobbying group sent to the FDA. [...] FDA officials acknowledged they weighed the PCPC's response to the citizens' petitions demanding a warning for talc-based powders before finding there was "inconclusive evidence" the mineral caused ovarian and other forms of cancer. "The FDA reviewed and considered all of the information submitted to us in the two petitions, the comments received in response to the petitions, and additional scientific information," said Tara Rabin, a spokeswoman.

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Unsealed Emails Show How J&J Shaped Report On Talc's Links To Cancer

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  • Sealed Emails (Score:5, Interesting)

    by dohzer ( 867770 ) on Monday November 08, 2021 @10:40PM (#61970331)

    What is a sealed email, and how do I start using them?

  • Luke had a link to the dark side the whole time?

  • Between J&J's carcinogenic talc, and Perdue and Pfizer's creation of the opioid epidemic that takes the lives of 16 per 100,000 Americans every year, we have tragic recent examples of the need for precautionary principles and regulatory rigor particularly as it relates to a lack of longitudinal data of mRNA therapeutic safety. It took the U.S. a decade - from 1999 to 2010 - to recognize the opioid abuse facilitated by the pharmaceutical industry was killing people in droves. We don't have a decade to wa
    • by Ostracus ( 1354233 ) on Monday November 08, 2021 @11:06PM (#61970359) Journal

      The question should be, why is asbestos being used in talcum powder?

      • by timeOday ( 582209 ) on Tuesday November 09, 2021 @12:26AM (#61970471)
        The answer is, is comes from the ground, and as much as you refine it, trace elements of various things remain. So you refine it some more. Over time the testing got more accurate.

        But the evidence is that it does not raise cancer risk.

        A study of more than 250,000 women between 1976 and 2017 found no significant link between womenâ(TM)s use of talcum powder on their genitals and ovarian cancer.

        https://www.webmd.com/cancer/t... [webmd.com]

        Of course, you can never prove definitively it didn't raise the risk by some amount too small to detect.

        J&J certainly had a dog in this fight, then again the other side is ambulance-chasing lawyers. In this case, J&J is right and the plaintiffs are wrong, if that matters to anybody.

        • It still would have made a lot of sense to recommend that users wear a face mask. I worked in the coatings industry for decades. Face masks are required when handling any and all pigments. Breathing a solid material in is not good practice. Workers got fired for not following the rules. Why was this common sense practice not presented to mothers and fathers. The bigger problem is protecting the baby from breathing in the dust. It can cause asthma.
          • The workers I would definitely put in a different category than anybody who used it a normal amount. But even then the page I linked says: "Some studies show a slightly higher risk in people who are involved in talc mining and processing. But it's not clear whether this is because of the mineral or because of other things underground known to cause lung cancer, like the radioactive gas radon."
          • But the thing is that the lawsuit is about for ovarian cancer, not asthma.
            I totally agree that there should be taken precautions against breathing a solid particle that is not absorbed by the body, specially if said person has high exposure (such as during work), and if I recall there is evidence that talc powder can accumulate in the lungs and cause issues, but there is no evidence that the same happens in the uterus/ovaries.
            In my view it is unethical for J&J to pick and choose who is going to make a r

        • Re: (Score:3, Funny)

          by flyingfsck ( 986395 )
          Fortunately it only causes cancer in California. The rest of us can carry on using talcum powder like people all over the world has done for thousands of years.
        • In this case, J&J is right and the plaintiffs are wrong, if that matters to anybody.

          Heretic!

        • How is J&J right? They knew that the product was tainted with asbestos and they concealed it. Whether that asbestos caused cancer or not is now a question for courts to decide. But their own concern and their concealing of the risk is not a fact in dispute. They could have labeled the product 99.99% asbestos free. How do you prove that an individual case is caused or not caused by the product? Probably the *average* level of asbestos might not be problematic but maybe some batches were more tainte
        • Exactly. It's Erin Brockovich part II. It captures the popular imagination ("evil company" always sells) but it's based on bullshit.
      • You're clearly anti-talc

        How dare you question talc, sir! I hope social media bans you. /s

    • by dunkelfalke ( 91624 ) on Tuesday November 09, 2021 @02:04AM (#61970547)

      The so called Pfizer vaccine has been created by BioNTech, a German company. The J&J vaccine has been created by Janssen Vaccines in the Netherlands and isn't mRNA based anyway.

    • Re: (Score:2, Insightful)

      ... evidence-based medicine.

      That doesn't stop big pharma telling sick people which medicine they should buy. It doesn't stop an insurance clerk deciding what medicine you're allowed to get. It doesn't stop a 'businessman' buying a monopoly product and increasing its price 16-fold. Plus, loud-mouthed nobodies can still claim medicine causes autism or contains tracking chips or grows a synthetic virus.

      This demonstrates how nothing the US government does is free from corporate interference or propaganda. Don't get me started on the

    • mRNA has been studied for decades now. https://www.nature.com/article... [nature.com]

      Although I will say the drug companies were complicit in pushing their "non addictive" painkillers that turned out to be pretty addictive.

      • Re: (Score:3, Insightful)

        by sideslash ( 1865434 )
        It is true that it has been studied for decades now. However there are zero studies of the long term effects of coronavirus spike generative mRNA therapy, because we haven't been doing it on people for very long.

        I get tired of intelligent people bald facedly lying about this. There are ZERO long term safety studies. ZERO. That's a ZERO with a decimal point and infinite ZEROs after it. Why lie? Why claim to be pro science when you are in reality just believing what you are told on the TV? It's befuddling.
        • Right. Thank God we had all the "muh long term studies" for, say, the polio or Smallpox vaccines, by gum! Really saved our bacon!
          • Right. Thank God we had all the "muh long term studies" for, say, the polio or Smallpox vaccines, by gum! Really saved our bacon!

            You can argue that it's a good idea to vaccinate the whole world without long term safety studies if you like, but you are absolutely insane to defend the mandates. Nobody should have to put their health at risk for a disease that tends to kill people near the existing average age of mortality for the population. And any kind of mandate or pressure applied toward universal mRNA COVID vaccination of children is deeply unethical in the absence of long term safety data. These kids have their whole lives in fro

    • by labnet ( 457441 )

      Great comment.
      Of my 50 plus years on earth, I’m flabbergasted by western governments fawning over new tech covid vaccines when there were alternative generics drugs and traditional protein based alternatives with just as good efficacy and much lower risk profile.
      This all stinks of malicious contracts and psychological manipulation by big pharma.
      The MIC and Big Pharma. Two evil dudes.

  • Talc doesn't cause cancer, the powder causes cancer if it comes with asbestos. [webmd.com] So the question is, how much asbestos was in the powder they were selling? Hopefully the answer is none.

    • Re:Cancer (Score:4, Interesting)

      by phantomfive ( 622387 ) on Monday November 08, 2021 @11:16PM (#61970369) Journal

      Here is the study that discusses asbestos and ovarian cancer [nih.gov]. It's not clear to scientists how asbestos causes ovarian cancer (as opposed to lung disease or cancer), but you can't conclude much from that. The link is small (some studies showed a decrease in ovarian cancer after exposure to asbestos, though on average across studies there was a small increase in risk), but appears to be statistically significant.

      • The title of the article cited is "Occupational Exposure to Asbestos and Ovarian Cancer: A Meta-analysis". It relates only to *occupational* exposure, which is *far* greater than the exposure one receives at home from a talc-based product that contains trace amounts of asbestos.
    • by ELCouz ( 1338259 )
      If you feel adventurous to read over hundred MBs of PDF reports on FDA website, be my guest!
      https://www.fda.gov/cosmetics/... [fda.gov]
    • by fermion ( 181285 )
      There are two issues here. The first a warning which could decrease sales but might have reduced current liability, the other is knowingly exposing customers to dangerous chemicals. This post has to do with the fact that if the company knew that there might be dangerous chemicals and did not warn customers then that might increase damages

      But the fact remains that Talc and Asbestos tends to be naturally located in the same regions and when one is mined it will contaminated by the other. And the emails show

  • by fredrated ( 639554 ) on Monday November 08, 2021 @11:25PM (#61970381) Journal

    they are two different minerals. So what does it have to do with asbestos-caused cancer?

    • by phantomfive ( 622387 ) on Monday November 08, 2021 @11:34PM (#61970397) Journal

      Reportedly, sometimes asbestos was in the talc powder they sold. As someone else pointed out, here is a link to the data [slashdot.org] (I don't know what it says).

      • by Gavino ( 560149 )
        It's like the chocolate bar warnings "May contain traces of nut".

        I guess talc needs a warning "may contain traces of asbestos".
      • by tlhIngan ( 30335 ) <slashdot&worf,net> on Tuesday November 09, 2021 @04:33AM (#61970629)

        Basically, what happened was J&J discovered that their talc contained asbestos. There was a huge class action lawsuit about this - that J&J failed to warn people that the talc they used contained asbestos and even worse, hid that data showing they knew it had asbestos in it.

        It's not just warning labels - it's more like not ensuring the purity of the product, especially one that is easily made airborne (asbestos is fine if it's locked up tight, but once it's airborne it's extremely dangerous).

        This happened many years ago - J&J has contained cornstarch in place of talc for a number of years now.

    • Asbestos and talc come from the same mines, they are often inter-mingled in the raw material directly from the earth itself. The tricky part is separating them during manufacture into useful products.

  • by OrangeTide ( 124937 ) on Monday November 08, 2021 @11:36PM (#61970403) Homepage Journal

    It seems like every major industry, from petroleum to pharmaceuticals to tobacco has a long history of hiring just the right "experts" to blind the public and distract politicians. After a while we build up a society that won't trust vaccines or climate change. Now the ignorant masses don't know who to trust, they're just sick of being scammed.

    • TRUST SLASHDOT! Would we steer you wrong?

      • None of us are paid to if that's what you're implying, we only do it because we think it's funny to trick gullible people.

        • None of us are paid to if that's what you're implying, we only do it because we think it's funny to trick gullible people.

          Jokes on you, when I change my mind all the minutiae of the world swirl in flux then suddenly lock into place as my resolve firms. Then reality is locked in and it’s stupid to think any amount of facts will sway me, if I decide to change my mind again they’ll just change anyway.

    • Well said.

    • Re: (Score:3, Insightful)

      by muvol ( 1226860 )

      You are right about being scammed. I'm with you. The trick is to do something about it.

      1. Keep score.
      When a person or organization lies to you, remember that; they will likely do it again.

      2. Do your homework.
      a. Find out something about the subject matter, and learn some of the terms.
      Wikipedia is usually a good place to start. Facebook is not.
      b. Look for independent, authorit

    • by jvkjvk ( 102057 )

      >Now the ignorant masses don't know who to trust, they're just sick of being scammed.

      I don't believe you are correct.

      They certainly trust *someone* who is selling them lies about vaccines and climate change. They seem to have very strong beliefs about it. So, no, they are trusting people, just outright liars, scammers, and thieves. Sorry to burst your rosy bubble.

  • It’s very unlikely the potential trace amounts of asbestos would really lead to cancer, and the scientific studies bear that out. You can’t just put a warning label on anything that could potentially cause cancer, you’d end up putting them everywhere and they’d become meaningless.

    • You can’t just put a warning label on anything that could potentially cause cancer, you’d end up putting them everywhere and they’d become meaningless.

      Have you been shopping recently? I don't live in California, but it seems as if the majority of products I buy have one warning or another alongs the lines of "contains products known to be harmful to the State of California".

      • by Anonymous Coward

        I don't live in California, but it seems as if the majority of products I buy have one warning or another alongs the lines of "contains products known to be harmful to the State of California".

        I know, right? Even a bag of tumeric comes with a Prop 65 warning: "May cause cancer in the State of California."

        This is why I don't live in California.

        • by burtosis ( 1124179 ) on Tuesday November 09, 2021 @08:04AM (#61970877)

          I know, right? Even a bag of tumeric comes with a Prop 65 warning: "May cause cancer in the State of California."

          This is why I don't live in California.

          Even worse, what everyone has been neglecting is all the horrible chemicals in those warning labels. Really, there should be a warning label on them.

          • I know, right? Even a bag of tumeric comes with a Prop 65 warning: "May cause cancer in the State of California."

            This is why I don't live in California.

            Even worse, what everyone has been neglecting is all the horrible chemicals in those warning labels. Really, there should be a warning label on them.

            You jest, but surely those stickers contain chemicals that, if force fed to mice from giant industrial drums, might cause some indigestion or something.

            You industry shill!!!

        • by NFN_NLN ( 633283 )

          > I know, right? Even a bag of tumeric comes with a Prop 65 warning: "May cause cancer in the State of California."

          > This is why I don't live in California.

          "May cause cancer in the State of California" but it doesn't say anything about Nevada... that's some big brain thinking OP.

        • Even a bag of turmeric comes with a Prop 65 warning:

          Even the FDA recalls turmeric because of lead contamination. The whole lead in your turmeric thing isn't just a bunch of pearl clutching hippies. (as stupid as prop 65 can be sometimes). There is a legitimate risk of lead in some sources of turmeric and consumers are generally unaware of those risks.

          This is why I don't live in California.

          What a curious way to decide where you will live.

    • THis is exactly what happened with the California Proposition 65 warnings. They're on everything! Every petroleum product, including plastic can cause cancer with sufficient levels of exposure (that you will likely never have). So, as a result, everyone ignores the warnings because they're meaningless.

      • by NFN_NLN ( 633283 )

        It's a metaphor for feminists and leftists. If you complain about everything it loses efficacy.

        • The problem with our system of government, things get fixed, or at least looked at, based on 'the squeaky wheel gets the grease' method. Those topics that catch the public's attention are what politicians focus on. As a result, everyone that has an issue they want addressed (and not just on the left) yells as loud as they can to catch people's attention. Due to this, you get a cacophony of noise that everyone ignores and the problems continue, ignored. Only when something rises above the rest does anyth

  • "While the practice of companies having a say in industry group submissions to the FDA isn't new or illegal,"

    I mean, who else would have a say in industry group submissions?

  • Iâ(TM)ve been taking something called NAC for years, and itâ(TM)s helped bring down my liver enzymes to normal levels. It smells like rotten eggs (sulfer) but I never been able to pinpoint any negative side-effects. NAC is basicAlly a powerful anti-oxidant and increase liver glutathione. Itâ(TM)s been on the market for at least the last 20 years.

    Recently, researchers found that NAC is helpful for people who have COVID, and it showed great promise in no reading survivability.

    Last month, Amaz

    • P.S. Fuck you in the ear for your multi-year refusal to deal with the fucking apostropheÃ(TM)s, Slashdot. You still think the iPad thing is a fleeting fad, eh?

      There's probably no one at Slashdot capable of making significant changes to the code. Judging by their inability to even do the job of a slashdot editor, which is laughably pathetic, they would surely fuck up the whole site if they tried.

      With that said, Slashdot doesn't really need your "smart" quotes. In fact, they are likely to fuck up code snippets or similar.

  • Well, maybe not "everything" that would be too obvious, but putting standard disclaimers on "categories" of things that have known but under-appreciated risks might give companies some cover.

    For example:

    "WARNING: The drug you are taking was approved for human use in [some year in the 21st century]. Long-term clinical data does not exist. Do not use if you are concerned about possible long-term side effects."

    Then, if people start coming up with cancers 25 years down the road, the company can say "it's not

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