Big-Pharma Kept Quiet About Cancer Risks of Zantac for 40 Years

By Jo Nova

zantac tabletsThe insidious vaccine debacle may seem to have come out of nowhere, but pharmaceutical and regulatory rot has been growing for decades.

The story of Zantac, the common heartburn medicine, is both awful and good – it’s awful because one of the most common drugs on the market may have been causing cancers for forty years. It’s good only because the story is finally being told and 70,000 people are suing GlaxoSmithKline (GSK). The “good” here is the hope that some justice might finally be done, and because the public might find out just how ghastly the industrial pharma octopus really is, and how welded it is in the system.

It’s time to burn down the unholy empire of Big Pharma and Big Government and start again.

This is not a case of one bad egg in the system, it’s the story of a system that virtually creates bad eggs

Glaxo was a little company in the 70s that took one of the most popular drugs on the market, Tagamet, tweaked it enough to patent a “better version”, then aggressively out-marketed it, and eventually bought out the companies that made Tagamet to become the $70 billion GlaxoSmithKline giant.

“By 1989, Zantac was worth $2 billion. It accounted for half of Glaxo’s sales and 53% of the market for prescription ulcer remedies.”

But the common heartburn drug Zantac, or ranitidine, which drove their profits — also broke down into NDMA which is a known carcinogen, and there were warnings of this in 1981 and 1982, but it wasn’t until September 2019 that an independent lab tested for NDMA and found it in every sample and at alarming levels. By April 2020 the FDA forced every manufacturer to stop producing and selling the drug altogether. Now, the court cases have started.

Most of the Bloomberg story — which is worth reading in full — focuses on just how badly behaved GlaxoSmithKline have been by hiding the early data for forty long years. But GSK also chose not to do more tests when it should have; it did not try to transport and store the drug in ways the reduced the contamination, and it did not advise the public to take the tablets outside meals. There is no sense that customer health mattered.

To me the bigger question that is never asked, is why drugs like this are not tested by publicly funded groups before they get approval to be rolled out en masse? The tests that were finally done in 2019 are not two-year studies involving thousands of people, they are just lab tests for contamination. What is the point of all the public health funding, the regulatory agencies, and public universities if they aren’t used to defend the public?

If the FDA has the legal power to approve drugs or ban them, shouldn’t it also bear the responsibility when it gets that wrong?

Under legal cross examination the director of research and development admitted they had known for almost 40 years that ranitidine could degrade under conditions of high temperature and moisture … .

Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years

Glaxo says the heartburn drug doesn’t cause tumors. But the company was warned by its own scientists and independent researchers about the potential danger. 

In 2019 the drug was found to be tainted with high levels of a probable carcinogen. Not by chance or mistake in a few batches. The poison is created by ranitidine itself. Zantac’s makers and health regulators around the world recalled the drug, and in the spring of 2020 the FDA forced it off the market altogether. No company could manufacture it; nobody should ingest it. The carcinogen, called NDMA, was once added to rocket fuel and is now used only to induce cancer in lab rats. The FDA says consuming minuscule amounts isn’t harmful. But tests were revealing excessive amounts of NDMA in ranitidine—and a capacity to create even more over time. No version seemed safe.

From ranitidine’s beginning to its end, Glaxo had been warned by its own scientists and independent researchers about the potential danger. An account of those four decades emerges in hundreds of documents, thousands of pages, many of which have never been made public. Bloomberg Businessweek reviewed court filings, many still under seal, as well as studies, FDA transcripts and new drug applications obtained via Freedom of Information Act requests. They show that the FDA considered the cancer risks when approving ranitidine. But Glaxo didn’t share a critical study. Over the years, the company also backed flawed research designed to minimize concerns and chose not to routinely transport and store the medication in ways that could have eased the problem. Glaxo sold a drug that might harm people, tried to discount evidence of that and never gave anyone the slightest warning.

Plaintiffs’ lawyer: At any time when Zantac had been on the market for almost 50 years, did Glaxo cause anyone to test for the presence of NDMA, a probable human carcinogen, in the product it was selling to American consumers known as Zantac?

Glaxo senior medical adviser: Not to my knowledge.

—Deposition, June 2021

NDMA, which is short for N-Nitrosodimethylamine, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste. It was first linked to cancer in 1956 and is most toxic to the liver. It’s one of a group of chemicals called nitrosamines, which by the 1970s were considered the most potent carcinogens yet discovered. They caused cancer in every species of animal tested. A single dose of less than a milligram of NDMA can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days.

Many people would end up taking Zantac for months, sometimes years, even decades.

Zantac tablets

The 1981 in-house study that Glaxo hid:

Glaxo asked one of its scientists to conduct his own tests: Richard Tanner, who worked in the biochemical pharmacology division. He got the same results. He identified as much as 232,000 nanograms of NDMA in some samples. When the FDA later deemed that a tiny amount of NDMA was acceptable in any drug, that amount was 96ng. Tanner didn’t find NDMA when he used a lower nitrite level, which the company now says is closer to conditions in an actual human stomach. But back in 1982, court documents show, Glaxo kept the study secret. The associate director of clinical research in the US was never told about the Tanner report. The senior medical adviser for gastrointestinal research was unaware of it. So was the FDA.

Their competitors which made Tagamet, even did a study told them in 1982 that their drug would form NDMA.

It’s all about the money, and GSK became the largest drug company in the world at one point:

Zantac’s sales in the US that first year were about $125 million, which made it one of the best launches of a drug ever. “

That year, Tagamet became the first billion-dollar drug. The next year, Zantac overtook Tagamet.

In 1995, Glaxo completed a hostile takeover of another British drug company, Wellcome. Five years later, in 2000, Glaxo Wellcome acquired its longtime rival, known then as SmithKline Beecham. It was the biggest merger in the industry’s history and created the biggest drug company in the world, GlaxoSmithKline.

GSK was hit with a $3b fine “the largest health-care fraud settlement in US history”

This had nothing to do with Zantac, it was for their next two top selling productions. Spot the pattern?

 In 2012 the company agreed to plead guilty and pay a $3 billion fine for marketing drugs for inappropriate uses, disregarding safety data and cheating Medicaid. The drugs were among the company’s most popular after Zantac: Paxil, Wellbutrin and the diabetes drug Avandia. The US Department of Justice called it the largest health-care fraud settlement in US history and the largest payment ever by a drug company. Two years later, China fined GSK $500 million and deported a top executive for bribing doctors to prescribe its drugs. The company told the BBC it had “published a statement of apology to the Chinese government and its people.”

In September 2019 the FDA received a 19-page document that made some alarming claims about ranitidine. Valisure, a private lab operating independently of the FDA, said it had found extremely high levels of NDMA in Zantac and several generic versions of ranitidine. Valisure had begun testing for NDMA the year before, when the FDA first recalled batches of the blood pressure medication valsartan because they were contaminated with it. This situation seemed worse. Valisure had found NDMA in every version of ranitidine it tested and concluded the problem was inherent to the molecule itself.

Read it all at Bloomberg

As a sign of how few people know how bad Zantac potentially is, the “new” version of it called famotidine is being marketed  “building on the Zantac brand’s established history and legacy.”

REFERENCE

Gerald McGwin (2020) The Association between Ranitidine Use and Gastrointestinal Cancers,  2021 Jan; 13(1): 24.Published online 2020 Dec 23. doi: 10.3390/cancers13010024

First  Zantac photo by ParentingPatch  |  Second photo by Editor182

 

9.5 out of 10 based on 68 ratings

72 comments to Big-Pharma Kept Quiet About Cancer Risks of Zantac for 40 Years

  • #
    Hanrahan

    Years ago a liberal gov wanted to introduce a co-payment for bulk billed doctor visits, the proceeds going into research. I was lukewarm, I didn’t want our gov competing with pharma looking for the silver bullet cure, which is rather elusive.

    Why not introduce the co-payment and have the cash fund research into “wellness” [including diet] and repurposing old drugs? No one else is doing it.

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      Let’s train some doctors in preventative medicine and study how well they can improve outcomes and reduce medical costs. People ought to be able to choose a doc with a different skill set to the usual GP. Competition…

      At the moment in Australia AHPRA controls what kind of GP Australians are allowed to visit. Alternative doctors are not even allowed to call themselves a doctor and treat patients, let alone get paid medicare.

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        And in QLD the dangerous Palachook govt has now legislated that doctors must follow what the bureaucrats determine as best practice. Of course, they completely ignored the utter debacle of covid where the govts measures were utterly wrong yet doctors who did not follow were sacked. A clear example how this does not work, but who cares, just keep on with the Leftist ideology.

        And its a good bet that preventative measures like proper vitamin D levels, exercise etc etc will be ignored in favour of WEF/UN/WHO dictates which nearly always accord with the interests of Pharma, not Queenslanders

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          Hanrahan

          But proper research should be able to influence/improve “best practice”.

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            GCRee

            True but I guess the biggest issues is what constitutes ‘proper research’. It should already have happened without saying it, but government regulators should not be able to rely exclusively on company produced data in accepting anything for approval. There should be a healthy skepticism applied to the information and independent, third party tests conducted free from bias. Everything is tainted TBH, we are only just finding out how deep the collusion is between Big Government and Big Pharma. Imagine if actual journalists now reviewed many other drug approvals to see if there was this type of misfeasance.

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  • #
    Leigh

    Thanks for this Jo

    Back in 2019 it was presented by the media (including medical media) as NDMA was found in a few Generic versions as contamination and so as a safety measure all forms of Ranitidine including Zantac were to be removed from market.

    I remember thinking at the time what a pity as it still was useful in a limited number of cases.

    The power of omission by the media!

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      That’s really interesting Leigh. I wasn’t paying attention as it’s not something I use. I wondered if people were aware of how serious the contamination was. Obviously not. Big-Gov, Big-Pharma and Big-Media all covering their own failure.

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    • #
      Dianeh

      I was on Zantac for a couple of years, until it was taken from the market. It is a H2 blocker and the H2 receptors are in the stomach and cause excess acid in the presence of histamine. It was wonderful, as it wasn’t until it took that with Zyrtec (H1 blocker) that I had any relief from my chronic hives.

      All ranitidine products were removed from sale in Australia and are still banned. In other countries ranitidine is back but not marketed as Zantac. When it was banned, there was a terrible shortage of this class of drugs. The article talks about Tagamet, which is one of the other H2 blockers, there are two more.

      Most people don’t need to take a H2 blocker, they will do fine with a PPI, like nexium. zantac should never have been prescribed in place of the PPI’s. it is an antihistamine and should have only been used for that. For people like myself, a PPI won’t help my reflux at all and of course won’t help with hives.

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      • #
        Sceptical+Sam

        Back in the 1990s when I was still working silly hours and under stressful conditions I was prescribed Zantac to treat the ulcers that I was advised resulted from my silly work situation.

        Subsequently, on change of medical doctor, I was put on Barry Marshall’s “Triple Treatment”. My new medical doctor holding the view that I had Helicobactor pylori infection picked up in China as a result of eating from a communal bowl into which everybody around the table dipped their chop-sticks. You had to be quick or else you went hungry.

        It took about three weeks. It was horrible. It did the trick. Mid way through I had a long-haul flight to Florida. I won’t go into the details but it wasn’t nice. (The flight – not Florida).

        Warren and Marshall deserve all their accolades as far as I’m concerned. The resistance and back-stabbing they underwent from the establishment was a disgrace. Jealousy. Vested interests who tried to prevent the use of cheap and readily available pharmaceuticals to treat Peptic ulcers. Shameful.

        Barry Marshall deserves his Nobel. Not too many of those from Kalgoorlie boys, I’ll wager.

        “During his gastroenterology rotation in 1981 Marshall met pathologist Dr Robin Warren. Warren and Marshall (working at Freemantle Hospital) together studied curved bacteria present in the stomachs of a number of their patients suffering from ulcers and gastritis. They discovered that peptic ulcers were due to Helicobacter pylori, not stress as previously thought. In 1984 Marshall did the ultimate test by infecting himself with the bacteria, developing the symptoms of the disease and then successfully treating himself with antibiotics. Marshall and Warren spent many years trying to convince the medical establishment of the validity of their work. In 1994 the World Health Organization accepted that H. pylori is a causative factor in stomach cancer. Their work received the Nobel Prize for physiology or medicine in 2005.”

        https://www.science.org.au/learning/general-audience/history/interviews-australian-scientists/professor-barry-marshall/teacher

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        • #
          Steve of Cornubia

          Back in the early 90s I worked for a small scientific instrument company making a special mass spectrometer used to detect H. pylori using just a breath sample. Marshall’s discovery in itself was groundbreaking, but the ability to detect the bacteria in such a non-invasive way made the whole thing just irresistible, and a guaranteed success.

          Or so you would think.

          For that little start-up, the key to it all was America, so all our efforts went into making sales there, for which we needed FDA approval (the instrument deemed to constitute a medical device).

          I can’t recall the details, only that the FDA rejected our application for approval, which meant that people would inevitably remain stuck with ‘treatments’ for symptoms of stomach ulcers rather than cures. A big win for Big Pharma.

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          Ronin

          “Vested interests who tried to prevent the use of cheap and readily available pharmaceuticals to treat Peptic ulcers. Shameful.”

          Now where have we seen this recently. !

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      • #
        Lawrie

        I won’t compare my very occasional gastric reflux/heartburn to your obviously more serious condition but I found my best relief came with a teaspoon full of sodium bicarbonate in water. I did take Zantac once or twice but found the sodium Bicarb just as good. I guess the burp that invariably follows adds to the CO2 content in the atmosphere which should help my plants.

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  • #
    David Maddison

    Surprisingly, Australia’s TGA did something right for once and suspended registration of Ranitidine on 2nd April, 2020.

    Big Pharma will be displeased. They pay a lot of money to ensure TGA doesn’t ask too many questions.

    https://www.tga.gov.au/news/safety-alerts/ranitidine-0

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  • #
    Ted1.

    Whe this one has been sorted out we should dig up the Hole in the Ozone Layer again.

    Never forgetting the Vaxes.

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    • #
      Lawrie

      One of the great benefits of the distrust of the MSM, and it is growing, is the plethora of blogs like this one and the development of on line news such as American Thinker, Epoch Times and Gateway Pundit. They are doing an amazing job of alerting many to the news that was and is being denied the public. The CIA inspired destruction of Nordstream 2 has been exposed on alternative media and now China, Russia and Germany are demanding answers. Not a peep from the MSM however.

      Supposedly fearless pursuers of truth such as Sky News still refuses to accept that Donald Trump won the last election and that Joe Biden is an illegitimate President. The latest estimation is that Joe received about 8.1 million fraudulent votes. A cursory examination of the overwhelming abundance of Republican won counties opposed to Democrat cities should ring alarm bells but crickets from the intrepid journos now known as stenographers.

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    Penguinite

    Zantac’s Maker Kept Quiet About Cancer Risks for 40 Years. GSK was hit with a $3b fine “the largest health-care fraud settlement in US history”. They’re now selling it in USA under a new name Famotidine. Trade names Pepcid, Zantac 360, and others. Beware the small print! The side effects remain! Big Pharma can’t be trusted https://www.drugs.com/famotidine.html

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  • #

    There is a very cheep and effective drug, natron, sodium bicarbonate, to buy nearly everywhere, besides it’s a very effective neutralizer.

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    • #
      Fran

      Effective if you have overeaten on an occasional basis. Consumed many times a day for ulcers, positively dangerous.

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      • #

        The normal dose is 1/2 teaspoon in a glas of water, 3 times a day, 1h before, 2h after meal.
        I used this dose for haunch problems for 2 weeks, with unexpected success (it was a trial)
        In case of sore throat, you may gargle for desinfection. It may help in case of coryza rinsing the nose.
        And it helps against hyperacidity.

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      • #
        Lewis P Buckingham

        Agreed. The sodium bicarbonate releases CO2 which is hopefully burped up , an acid gas that neutralises the stomach acidity. The problem though is that the CO2 stimulates the stomach to manufacture more acid so you have to take more Bicarb to neutralise it. You endup loaded with salt and still needing more bicarb.

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    • #
      Hanrahan

      Why the urge to reduce acidity? My reading has me believe that as we age we have trouble maintaining the stomach acidity needed.

      And we have known for years it isn’t acidity causing stomach ulcers.

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      • #

        Metabolic Acidosis

        When your body fluids contain too much acid, it’s known as acidosis. Acidosis occurs when your kidneys and lungs can’t keep your body’s pH in balance.

        Many of the body’s processes produce acid. Your lungs and kidneys can usually compensate for slight pH imbalances, but problems with these organs can lead to excess acid accumulating in your body and blood.
        The acidity of your blood is measured by determining its pH. A lower pH means that your blood is more acidic, while a higher pH means that your blood is more basic.
        The pH of your blood should be around 7.4. Acidosis is characterized by a pH of 7.35Trusted Source or lower. Alkalosis is characterized by a pH level of 7.45 or higher.
        While seemingly slight, these numerical differences can be serious. Metabolic acidosis can lead to numerous health issues, and it can even be life threatening.

        That may explain what I mean.

        Btw., I didn’t talk about ulcers.

        But you may have at the back of your mind, natron is able to stop inflammation processes.

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  • #

    With Pharma, they appear to just look at fines as a “cost of business” and could not really care less as their profits far eclipse any fines, even billion dollar ones.

    What we need to do is legislate so that the executives of these companies and those providing false information on these products are personally taken down. Jail time, bankrupted, not allowed to serve in leadership positions in the future etc etc. Until we have these criminals unable to ply their trade the current complete charade will continue.

    But, as we have seen from the debacle of covid, many of our politicians seem to have been bought off, together with the TGA and others, so this would be a difficult one to get done. But it needs to be done.

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  • #
    Simon Thompson ᵐᵇ ᵇˢ

    So the Billion dollar drug turns out to be a complete Dud. I am seeing a pattern.

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  • #
    Ross

    What’s new at the zoo? Nothing really. Go to your friendly web browser and type in “List of withdrawn drugs” with Wikipedia as your additional search item. There, you will find a list of all the drugs approved for use and then withdrawn mainly due to adverse reactions. Many of them in most recent times. Look at that list and them you will realise how pharmaceutical research has enormous shortcomings in terms of research. In effect, if a candidate active ingredient shows potential of efficacy for disease/symptom/ disorder it’s rushed to market. Side effects? Who cares as long as you can show it works. After all, all drugs have side effects. This is also what happened with mRNA vaccines, except in that case it was worse because it was literally a military operation ( Warp speed ) to get those products to market.

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  • #
    David Maddison

    AT the present rate, we can look forward to the defective and dangerous Covid vaccines being withdrawn around 2063. If anyone is still alive by then…

    But hey, that’s still sooner than the FDA’s original proposal of releasing Pfizer documents which was to take between 55 and 75 years*.

    *https://www.medpagetoday.com/special-reports/exclusives/97544

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  • #

    “What we really need is to burn down the unholy empire of Big Pharma and Big Government and start again.”

    So very, very true. If only…………………

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    • #
      Honk R Smith

      I think Big Pharma and Big Government along with Big media and Big Education are already doing a banging job of burning everything the frig down.
      We that became aware of the AGW scam watched them start the fire.
      We were too civilized to make a scene.
      We’re still debating with them.
      Throwing ‘science’ at them while they pummel us with lies.
      Now they’re making it illegal to call them arsonists.

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      • #
        GCRee

        Throw in the Charity Industrial Complex as well, largely funded by taxpayers, and you have the the Big 4 that will hopefully people will become aware of and lead to destruction of institutions and trust in the system. I find it so interesting that there are numerous more people protests around the world when government decisions are finally being felt by ordinary people.

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  • #
    Fran

    In the days before antibiotic treatment for ulcers, cimetadine (Tagamet) was a lifesaver but it had to be taken 4 times a day. Ranitadine was billed as a longer acting drug. I can testify that it is a crappy drug. I always thought the reason it was made over the counter was because of that.

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    • #
      Dianeh

      Cimetidine and Ramitidine are H2 blockers. They block histamine from reaching the H2 receptors in the stomach. The H2 receptors in the stomach produce excess stomach acid in the presence of histamine. So the more histamine, the more acid. Most people’s excess acid is not because of histamine intolerances. There are plenty of alternatives for them. But these newer drugs must not have been the cash cow that Zantac was.

      H1 histamine receptors are in the skin, and cause hives. So it is very unlikely that someone with a histamine intolerance would only have reflux, they would also have hives. H2 blockers are part of the treatment for chronic hives.

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      • #
        Ross

        Beautiful explanation Dianeh. Makes you wonder if general OTC anti-histamines (Zyrtec, Telfast etc) might also have positive effects vs acid reflux. Or, is that one of those dirty little medical secrets like some antibiotics have anti-viral effects?

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        • #
          Dianeh

          I wish you were right but sadly no. H1 antihistamines don’t help with reflux. H2 antihistamines though do boost the effectiveness of H1 antihistamines. The research papers I have read can’t really explain why.

          I have chronic hives which are controlled by H1 and H2 antihistamines plus a concoction of supplements that resembles the Covid concoction. I have researched all of this extensively looking for a cure that does not exist. PS I never got Covid.

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          • #

            So the more histamine, the more acid. Most people’s excess acid is not because of histamine intolerances.

            Dianeh: I don’t quite follow that … But I note this site on histamine intolerance agrees that “alcohol, tomatoes, citrus, chocolate, caffeine, fatty foods (including nuts and seeds) and spices” (higher histamine foods) were thought to increase GERD but apparently the link didn’t really pan out. They go on to recommend curcumin and Nigella Sativa (black seed oil)

            Curcumin Curcumin may be another solution. In a 2010 study of 14 people on proton-pump inhibitors (PPIs) or H2 receptor antagonists, 2 grams per day of curcumin was given. After 2 weeks, everyone came off their medication. Two months later, 11 out of 14 were completely without symptoms and no longer needed medication. The 3 who did not respond to the curcumin treatment needed a lower dose of PPI than before. Enjoy some turmeric/golden milk tea before bed, and see how you feel. Curcumin may affect the diamine oxidase (DAO) histamine degrading enzyme. Nigella Sativa Nigella has been used for digestive issues, including GERD, traditionally throughout Asia. Multiple studies back its effectiveness as an H2 receptor antagonist (antihistamine). You can read more about nigella here.

            Certainly those on prescriptions might be a lot better off if curcumin (tumeric) and Nigella sativa (black seed oil) helped solve the issue and reduce the drugs. Both of these were also recommended in Covid studies.

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              Dianeh

              I have excessive histamine in my body, I am allergic to myself. The more it increases, the more hives I get due to the H1 receptors in the skin.

              I also get bad reflux as the H2 receptors in the stomach react to the increased histamine and produce more stomach acid. When I am covered in hives ( and at times have had up to 80% of my body covered in hives and welts) my reflux was so bad I couldn’t swallow and had to go to the ER.

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            • #
              Lawrie

              All I know is I get heartburn when I eat such things as fatty pork belly.

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      • #
        Rupert Ashford

        Very interesting, and close to home. How do you control it now?

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        • #
          Dianeh

          2 x Zyrtec, 1 x Nizac (another H2 blocker) – morning and night.
          When acting up also add in a Telfast or if I haven’t slept for a couple of nights Phenergan.

          I also take vitamin c and d, zinc, quercetin (which has been a life saver) and probiotics.

          Although diet is not the cause, it aggravated the condition so as little gluten, sugar and dairy as possible. As my hives get better I can eat and drink more things.

          I have this since 2018. I am on a FB support page and since the Covid vaccinations we have had hundreds of people join, and the other related groups (eczema for eg) are experiencing the same thing.

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  • #
    Robert Swan

    It’s time to burn down the unholy empire of Big Pharma and Big Government and start again.

    There are sins on both sides, but “starting again” will just let it re-emerge like the baddie in Terminator 2. Fix the bit we fund directly. There would be no problem if the government regulator really did what it was meant to do and keep the bastards honest:

    “Oh, a bribe. Thanks, that looks very attractive. Off to chokey with you”
    “Hi there. Just popping in to interview these people who have been excluded from your results”.
    “Never mind us, we’re just running our own trial to make sure that this drug really *is* more effective than the old one out of patent”.

    Kick heads at FDA, TGA, MHRA, etc., and get them to do their jobs.

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    • #
      Simon Thompson ᵐᵇ ᵇˢ

      The TGA should be PROACTIVE. In years gone by, the plurality of drug companies meant that the competing drug manufacturers would help weed out bad drugs.
      Suppose I want to see if Drug A is all it is cracked up to be. The intelligent way to interview drug reps is to ask reps from the competition about the limitations Drug “A”- and they would dish it out truthfully-as they would fear being sued for libel. Repeating this process for the main drugs in a class gives you a feeling for what is the best drug to use. Unfortunately, drug reps talking about their own drugs will ignore the negatives by and large.

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        Ross

        The major problem with pharmaceutical development, in terms of efficacy studies, is that a candidate active ingredient is only required to show efficacy vs a control ( placebo ) group. Hence, marginally efficacious products can be developed and approved for use. In other similar industries where regulatory approval is required, your new wonder drug “X” must show efficacy at a similar level to an industry standard. This procedure then encourages a process of continuous improvement.

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        • #
          Simon Thompson ᵐᵇ ᵇˢ

          My fave example of this is taking the active isomer (mirror image) of an already patented molecule and getting a patent for the Isomer on the basis that it is more effective than the original drug (which contained both isomers).

          On a side note, the ankle depth of the drug pipeline means that Cash Cow (Vacca) is promoted- even thought they are unnecessary, ineffective and dangerous.

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          • #
            Ross

            That example is certainly a way of prolonging the marketing life of a product, I agree. The original has 2 isomers and then “hey presto”, just as the patent is about to expire on it, the company releases a new more refined product based on the more active isomer. It can then sell the newer product under patent protection with higher margins. But the product essentially has no better efficacy than the original. Then you get into the argument about patent lives and this blog is too short for that discussion.

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          • #
            Robert Swan

            Simon Thompson ᵐᵇ ᵇˢ,
            If the TGA (FDA, etc.) did its job properly, it would refuse to put the new drug on the PBS unless it performed significantly better than the one with the expiring patent. No return on investment might put the drug companies off these pointless tweaks. They do them because they know they have a tame regulator.

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      • #
        Grogery

        The TGA should be PROACTIVE.

        While the TGA is almost fully funded by the industry that it is supposed to regulate, I can’t see that happening.

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    • #
      Honk R Smith

      “There are sins on both sides.”

      Yep, so pick one.

      No just kidding, I’m participating in the civil erudite discussion about possible solutions.
      Lacking in erudition, but totally civil.
      I certainly have no reason to be uncivil about helping well meaning public policy leaders do a better job next time around, being one of the many little people that had their livelihoods destroyed, so intellectual detachment is much easier now.
      Unlike me, they are erudite and credentialed.
      They only intended to do good.

      Just makes me think of my dear departed Pappy.
      A grizzled, hard as nails, WWII platoon sergeant.
      He used to say, “us Americans were just as mean as the damn Germans.”
      Yep, sins on both sides.
      Poor guy was forced to pick one.
      Fortunately we’ve progressed beyond that.

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      “There are sins on both sides, but “starting again” will just let it re-emerge”

      Robert, I should have spelled it out further, but my idea of “starting again” means a total redesign of the system to get the incentives to line up in favor of The People. I want to start that conversation. Somehow we need to figure out how to keep these teams independent so Big Pharma can’t just “pay to play” by offering golden jobs to agency members (or gain influence through their children).

      We also need to separate Big-Pharma and Academia — there must be some kind of firewall, otherwise Universities just become subsidiaries of Big Pharma, pushing their drugs and staying silent on natural alternatives.

      If the TGA / FDA were held accountable for bad decisions in both the media and in the courts, they might think twice.

      At the moment, the system of patents and profits means there’s no incentive for industry to promote natural or out-of-patent drugs to solve a problem.

      But where are our Health Ministers? They should be looking for cheap solutions to saving lives and reducing costs on the health system, but we see none of that.

      And where are our doctors? The AMA or other groups don’t speak up to point out how much money is wasted on prescriptions that could be solved by fixing nutritional deficiencies. Doctors don’t have any interest in preventative medicine — it just reduces the customer base. But doctors are barely trained in nutrition anyhow — and that’s probably not an accident. Who benefits from that… ?

      And Big Pharma shouldn’t be paying advertising money to the media for prescription drugs which stops the media criticizing Big Pharma.

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        Robert Swan

        Jo,
        Fair enough.

        The TGA used to do a pretty good job. Twenty years or so ago they would reject some new drugs on the sensible basis that they cost too much and trial data showed they were no more effective than the older drugs. Big pharma wasn’t happy and I have heard that the US government lobbied the Australian government to clip the wings of the TGA. It seems they now just take their orders from the FDA. A very expensive rubber stamp.

        I’d quibble on your second last paragraph. Never expect the AMA to represent doctor or patient interests, they’re just another union, and in league with AHPRA to bully doctors into submission. Lastly, surely doctors’ prescription books are full of (supposed) preventative medicines: i.e. statins.

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        GCRee

        I do wonder why there can’t be bans on advertising. Not like the government hasn’t forced that with tobacco. In any event, if Doctors and Chemists are regulated through AHRPA etc to be the single source of information about drugs rather than more natural remedies – why do Big Pharma have to advertise to the public anyway? For some part a lot of what they sell can’t be bought over the counter, it needs to be prescribed.

        I understand then the larger the incentives to prescribers but I saw somewhere else requiring practitioners to disclose who gives them anything, and wear the doctor coat but have on it the labels of all of their sponsors – just like sports teams. And like in Financial Planning, all disclosures must be made, even gifts in kind – to the person and the practice.

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        Lawrie

        You answered your own question Jo. The solution to many if not all our problems is a truly independent media of which you play a big part. It is here now and expanding. The MSM are losing subscribers and the little independents are getting bigger and more professional. Newsmax was cancelled not because it was telling porkies but because it was gaining viewers at the expense of some lesser left wing outfits. GP has a huge following. Any Republican who wants to gain or maintain office knows they have to be seen on the alternative media because that is where their audience is. The perpetual liars on MSNBC and CNN are losing viewers as people seek real news and importantly the truth. The left are panicked by Musk Twitter so much so that our ABC has dropped out of Twitter; couldn’t take the adverse comments apparently.

        More people are speaking out against the ridiculous. Sturgeon, Ardern saw the writing on the wall and deserted. Hopefully Trudeau will be next followed swiftly by Albanese. The tide is turning and you have been a great help. We will win.

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    Simon Thompson ᵐᵇ ᵇˢ

    One contaminant in mRNA Jabs is DNA from the plasmids used to produce mRNA. Evidently Pfizer is 10x the level arbirarily set. The plasmid codes antibiotic resistance to Neomycin and Kanamycin- Who knows what effect this could have with the recipient’s microbiome?

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    Adellad

    Agree fully that Big Pharma is one part of a system so corrupted that there seems no pathway out. The two world wars did more than just bleed the West of its best young men, it also bled any remaining belief in our destiny to keep going forwards, to lead Humanity, to believe in ourselves and to innovate. This soul cancer has reached its apotheosis with today’s white self-hatred, the growth of Big Government/Big Oligopoly Fascism, perversion, declining birth rates, ugly “art” and architecture, collapse of Christianity and so on.
    The evils of Big Pharma are a tributary of a very big toxic river that we are all wallowing in towards oblivion.

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      Robert Swan

      Adellad,
      There were quite a few tech advances following WWII (television, space missions, computing, etc.), so I don’t think the World Wars were the cause. Might even be the lack of the Cold War that first made people optimistic, then complacent, then apathetic.

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      KP

      It is the endless cycle all empires go through, like life itself-

      The struggle at the start to overcome other proto-empires, then the growth and wealth that comes from ruling the world, the maturing of the empire and the changes of moral direction and culture as they no longer have to struggle for the capital they have accumulated, and then the long decay as younger proto-empires take over.

      The empire may fade into obscurity like Spain and Portugal, or vanish completely as most do when the borders are redrawn hundreds of years later.

      We saw Britain spend the 20th century collapsing and the USA rising, and now the USA’s time is done. Being bigger and better of course, it will take all the West with it. This is the Asian century.

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    Leo G

    My father and I both suffered episodes of GORD and were early users of ranitidine (Zantac) and later pantoprazole.

    The meds were not particularly effective.

    After years of consultations with gastroenterologists and other medicos which did not lead to a resolution of the problems, we noticed that our post-natal records showed a fail-to-thrive syndrome.

    Armed with that information we were able to verify that the problem was a deficiency of a galactolipase (human pancreatic lipase-related protein 2) which can be serious in infants but the effect of which is readily managed in adults by eliminating two particular short-chain triglycerides from the diet- components of butterfat.

    A simple solution, but one beyond the competence of medical specialists to identify.

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      Rupert Ashford

      Explain more please? What do you avoid in your diet to achieve that?

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        Leo G

        What do you avoid in your diet to achieve that?

        The short-chain triglycerides (SCTs) are a minor component of butterfat. I necessarily avoid butter and products with a significant butter content, cream, full-cream milk and to a lesser extent low fat milk and most cheese varieties.

        The SCTs in milk become rancid more rapidly than other components of butterfat, so dairy products with reduced SCTs tend to have a longer shelf life. Most natural yoghurts are OK but other yoghurts have added cream.

        There is a milk product available in Australia (New Zealand A2 brand milk) which is low in SCTs, but most other brands of A2 milk are not tolerable.

        If you have a history of GORD and your physician has taken you down the route of bile duct and gallbladder imaging with inconclusive results, I believe it’s worth trying the dietary exclusion of butterfat for a few months.

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    John Connor II

    It’s time to burn down the unholy empire of Big Pharma and Big Government and start again.

    Heh…😎

    For those suffering from “Heartburn”/ reflux/GERD, you may be interested to know that it’s not too much or too strong acid that’s the problem but rather the opposite.
    Taking antacids and similar will typically make it worse.
    Counter-intuitively you’re better off with Apple-vider vinegar (most readily available, but other products are as good).
    I can see the faces of disbelief already but try it. No cancer risks either…

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      Ross

      So many other factors as well, such as coffee, which may decreases lower esophageal sphincter (LES) pressure, which allows acid upwards. Lowering acid levels just makes no sense, because stomach acid helps digestion but also guards against infections.

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    Philip

    I did 3rd year biostats at Uni – out of interest, non core – and bioassay was fascinating. It showed how lengthy a trial was and how exhausting the process was to thoroughly test a drug. To the extent it was basically impossible. I expressed my amazement to my lecturer at the end of a tutorial one day and he said, ” so what do you think they know about most of those drugs on the shelf?” “not much?” was the obvious reply to the loaded question, to which he confirmed.

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      Philip

      in fact, is 53 too old to consider studying biostats properly, another degree? My first degree I wrote guitar riffs and drank a lot and grew vegetable gardens. But I really enjoyed stats. I know Id be competent at it if I studied, but you have to study. ?????

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    Macspee

    Many years ago in the mid 90’s I listened to a talk by a vet who said that vets knew that dogs gor stomach ulcers and were treated with antibiotics because they knew ulcers were bacteria caused. Has any one heard this?

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    Mr Robert Christopher

    Mark Steyn up and running again, and reporting on Fauci:
    https://youtu.be/Gt6_1ggBddM

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    Craig

    Could tell you about some of its dodgy marketing practices as well in the attempt to get reps to flog crap products as well…

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    AG

    It gets worse. They also marketed liquid Zantac for babies with heartburn.

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    Billy Bob Hall

    From ChatGPT.

    “In September 2019, the US Food and Drug Administration (FDA) announced that it had discovered low levels of a cancer-causing impurity called N-nitrosodimethylamine (NDMA) in the popular heartburn medication Zantac, also known as ranitidine. The FDA recommended that consumers stop taking the drug and that manufacturers recall it from the market.

    The discovery of NDMA in Zantac has led to numerous lawsuits and investigations, with some alleging that pharmaceutical companies knew about the potential cancer risk of the drug for decades but failed to disclose it to the public. Some of the lawsuits claim that companies continued to sell the drug and promoted it as safe despite knowing about the cancer risk.

    There is evidence to suggest that pharmaceutical companies were aware of potential NDMA contamination in ranitidine as early as the 1980s. However, it is important to note that the link between ranitidine and cancer is still not entirely clear and further research is needed.

    The case of Zantac underscores the importance of transparency and accountability in the pharmaceutical industry, as well as the need for rigorous testing and monitoring of drugs to ensure their safety for consumers.”

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    Leo Morgan

    Your bolded question “If the FDA has the legal power to approve drugs or ban them, shouldn’t it also bear the responsibility when it gets that wrong?” sounds like something that would be desirable in an ideal world.
    But in the practical world we actually live in, it is equivalent to “Shouldn’t Leo pay when mistakes are made by employees appointed by the nominees of politicians he voted against?”
    From my point of view the answer to that is hell no!

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