Health & Fitness

Heartburn is one of the primary symptoms of gastroesophageal reflux disease (GERD). It feels like a burning sensation behind the breastbone, which can move to the neck and throat. Sometimes you may also taste a sour, bitter fluid, which is the regurgitation of stomach acid from your esophagus.¹ Some individuals with GERD may also have other symptoms such as asthma, cough and laryngitis.

GERD is a common problem with an increasing prevalence in the general population. Traditionally, the incidence was higher in middle-aged and older adults.² However, there recently has been a rise in the number of younger people (30 to 39 years) who are seeking medical care for GERD.

The severity of heartburn appears to correspond with major life stressors. Researchers have not found that severity increases with fluctuations in mood but rather from sustained stress, which exacerbates heartburn symptoms.³

The current pandemic has raised the stress levels of many people who are filling more antianxiety, antidepressant and anti-insomnia medications than in the same period in 2019. The increase in prescriptions represents a sharp difference from the decline in antianxiety and anti-insomnia medications prescribed from 2015 to 2019.⁴ The authors of the report noted:

“This analysis, showing that many Americans are turning to medications for relief, demonstrates the serious impact COVID-19 may be having on our nation’s mental health.”

Heartburn Medication Associated With Diabetes

Long term use of proton pump inhibitors (PPI) to control heartburn, such as Nexium, Prevacid or Prilosec, has been linked with significant health conditions. The authors of a recent study published in the BMJ journal Gut sought to evaluate the association between regular use of PPIs and Type 2 diabetes.⁵

They undertook a prospective analysis of 204,689 people enrolled in three ongoing studies, including the Nurses’ Health Study. In this cohort they found 10,105 cases of diabetes. People who regularly took a PPI had a 24% increased risk compared to nonusers.

The researchers found that regular use raised an individual's risk of Type 2 diabetes and the risk grew with the length of time an individual took the medication. They concluded that “Physicians should therefore exercise caution when prescribing PPIs, particularly for long-term use.”⁶

There is evidence that PPIs alter the gut microbiome, which may trigger an association with Type 2 diabetes. In one study of 1,827 healthy twins, researchers found that PPI use was associated with a lower number of gut microbiota and lower microbial diversity.⁷

Researchers leading a separate study found that oral microbiota were over-represented in fecal microbiomes of people who used PPIs consistent “with changes towards a less healthy gut microbiome.” These changes are also in line with “known changes that predispose to C. difficile infections and can potentially explain the increased risk of enteric infections in PPI users.”⁸

Additionally, PPIs may increase the risk of “weight gain, chronic liver disease and metabolic syndrome.”⁹ Each of these conditions can increase the risk for Type 2 diabetes.

As pointed out in Medpage Today, there were limitations to the PPI-diabetes study as it was observational and the researchers could not exclude other confounding effects, such as PPI dosage, frequency and brand. Study authors were cited in the Medpage Today article as saying:¹⁰

“At a population level, PPIs may have an even more pronounced effect on gut microbiome than other commonly used drugs such as antibiotics, leading to warnings of overuse of PPIs and calls for further investigation into the sequelae of long-term PPI consumption.”

Alternative Over-the-Counter Medications Contaminated

In addition to prescription PPIs, there are over-the-counter medications for treating heartburn. Two of the medications, Zantac and Axid, have tested positive for the carcinogenic N-nitrosodimethylamine (NDMA) once used in the commercial production of rocket fuel.¹¹ 

The results from animal testing showed that it significantly increases the risk of cancer, so the chemical is now used only for research purposes. In February 2020, the heartburn drugs and others were recalled due to contamination with NDMA.^12,13 Since the compound may be absorbed from the environment, food, tobacco or medications, the FDA established an acceptable intake level of 96 nanograms per day.

As a comparison, this is 0.000096 of 1 milligram (mg) and a grain of salt is about 1 mg.¹⁴ One lot of recalled high blood pressure medication valsartan tested at 200 times this limit.¹⁵ Disturbingly, the authors of a 2019 report in Bloomberg suggested the contamination may have been the result of prioritizing profitability over quality testing and streamlining manufacturing methods.¹⁶

However, this isn't the first time carcinogens like NDMA have gotten into the generic drug supply, which raises serious questions about the FDA’s ability to ensure drug safety. As reported by Bloomberg, one of the blood pressure medications contained as much as 17 micrograms per pill, which is estimated by European health regulators to trigger cancer in 1 in every 3,390 people.

Disturbingly, a lax FDA approach to inspections that reveal faked quality testing is not unusual. Bloomberg spoke to Michael de la Torre, who runs a database of FDA inspections.

According to Torre, in the five years up to 2019, the FDA issued warning letters in response to faked data just 25% of the time. The bottom line is, this exposure resulted largely from a reliance on drugs for a symptomatic bandage that in no way treats the cause of the disease.

List of Dangers but No Special Monitoring for Long-Term Use

As I’ve written before, PPIs are linked to several negative health conditions. For example, long term use of proton pump inhibitors encourages bacterial overgrowth in your digestive tract,¹⁷ leading to the malabsorption of nutrients linked to inflammation of the stomach wall.¹⁸

PPIs also reduce the absorption of magnesium.¹⁹ Low magnesium levels can lead to nausea, fatigue, muscle contractions, personality changes and an abnormal heart rhythm.²⁰ By reducing the amount of stomach acid,²¹ PPIs increase your risk of heartburn, indigestion, bloating, diarrhea and gas.

Lowering your stomach acid may also reduce the amount of calcium absorption, which can lead to osteoporosis.²² Research data has linked long-term, dose-dependent use with an increased risk of hip fracture.²³

As described in a JAMA article, scientists speculate the rising number of people diagnosed with chronic kidney disease may be attributed to the increased number of people using PPIs.²⁴ Lead author Benjamin Lazarus, from the University of Queensland in Brisbane, Australia, comments:²⁵

“Study findings suggest that up to 70% of these prescriptions are without indication and that 25% of long-term PPI users could discontinue therapy without developing symptoms. Indeed, there are already calls for the reduction of unnecessary use of PPIs."

Your risk of stomach cancer also more than doubles when you take PPIs. Researchers factored in the potential role that infection might play in the development of stomach cancer and found those who took PPIs every day had 4.5 times the risk of stomach cancers as those who took the drug once a week.²⁶

Each of these health conditions are potential long-term risks. However, in a recent study of 86,602 respondents, researchers found people taking a PPI twice a day had four times the risk of those who did not take the drugs.^27,28

There are those who are not yet convinced that the use of PPIs comes with dangerous adverse effects. Dr. Daniel Freedberg from Columbia University, who was not involved in the study, spoke with Medpage and called the results “very weak.”

Despite mounting scientific evidence that the drugs cause significant and potentially dangerous side effects, Freedberg points out that the medical association that develops clinical guidelines, the American Gastroenterological Association, has not advised monitoring patients using long-term PPIs for adverse side effects and the current study is unlikely to change the status quo.²⁹

What Causes Heartburn?

Digestion of your food begins in your mouth as the food is broken into smaller pieces and mixed with saliva. Once in the stomach, food mixes with hydrochloric acid³⁰ and moves into the small intestine. Inside the stomach there is a muscular valve called the lower esophageal sphincter that prevents food or acid from moving back up.³¹

When this sphincter relaxes inappropriately it allows acid to reflux into the esophagus and burn tissue that cannot withstand the low pH. As I’ve written, in extremely rare situations, acid reflux is caused by an excessive amount of acid in the stomach. However, in the vast majority of cases acid reflux, heartburn and GERD are related to:

• Insufficient stomach acid³²
• Helicobacter pylori imbalance³³
• Hiatal hernia³⁴
• Food allergies³⁵

Consider this simple test as a rough indicator of how much acid your stomach produces. By finding out if your stomach acid level is low it will help you develop a plan to reduce your chronic pain.

1. Mix 1 teaspoon of baking soda in 8 ounces of cold water and drink it first thing in the morning, before eating or drinking anything. The combination of baking soda and hydrochloric acid in your stomach creates carbon dioxide gas, causing you to belch.³⁶
2. Time how long it takes you to form enough gas in your stomach to belch. Belching in two to three minutes is normal; earlier and repeated belching indicates an excess of acid. If you don't belch after five minutes, you may not be producing enough acid.

More accurate testing involves taking a stool sample to determine whether you might have an enzyme and/or hydrochloric acid deficiency.³⁷ It could also identify bacterial or fungal imbalances that might contribute to your condition.

Steps to Heal GERD and Avoid Heartburn

Research has also shown that both sauerkraut and cabbage juice can stimulate your body to produce stomach acid.³⁸ Using fermented juice from raw sauerkraut before your meal helps to naturally balance and nourish your gut with valuable bacteria and improve your digestion.

Reseeding your gut with beneficial bacteria not only helps balance your bowel flora but helps reduce or eliminate helicobacter naturally. Fermented foods and high-quality probiotic supplements help achieve these goals.

It is important to be aware that lectin-rich foods, such as grains and legumes, are potent enzyme inhibitors.³⁹ This may reduce the function of your digestive system and produce or exacerbate heartburn.

Address Heartburn Without Hazardous Drugs

If you're currently taking PPIs, it's vital you do not quit cold turkey. This can result in severe rebound acid hypersecretion.⁴⁰ Instead, spend time detoxifying and eliminating it from your system by gradually weaning yourself off the drug.

Once you are down to the lowest dose, begin substituting the medication with an over the counter H2 blocker, such as cimetidine or Tagamet. After taking the H2 blocker without the PPI for a couple of weeks, you can start weaning from these drugs as well.

In the process, begin introducing alternative options to reduce your heartburn. Although heartburn is painful, there are also long-term side effects from the chronic burning in the esophagus, including:^41,42

• Eosinophilic esophagitis
• Barrett’s esophagus
• Adenocarcinoma
• Peptic stricture
• Erosive esophagitis

You have options at home to effectively treat heartburn, GERD and indigestion without using hazardous or habit-forming medications. I outline several, some of which will also improve your overall health, in “Heartburn Drugs Increase Mortality — How to Safely Address Indigestion.”

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If you’re like most people, you probably assume that the U.S. Food and Drug Administration is funded by the U.S. government and therefore isn’t catering to private industries.

The agency itself certainly tries to present itself as independent from the industries it regulates but, in reality, legal loopholes have led to the FDA receiving money from, and being captured and corrupted by, private interests.

While the FDA itself does not accept corporate money, it does receive money funneled via a nonprofit foundation, which in turn receives money from other nonprofits funded by private interests. It’s really all a façade because the end result is the same. Those donating the money ultimately end up with the ability to pull strings, when needed.

The Reagan-Udall Foundation

As explained by NPR¹ back in 2012, the Reagan-Udall Foundation is a nonprofit foundation created by Congress in 2007 to support scientific research that is of interest to the FDA. According to NPR:²

“The idea was that this foundation could do things the FDA can't. It would raise money from private sources, fund research in areas where the FDA lacks expertise, and organize collaborations involving industry, patient groups and academia.”

As explained in a 2008 article³ in the Journal of the National Cancer Institute, the creation of the Reagan-Udall Foundation was part of a larger plan to establish a private-public partnership to facilitate the Critical Path Initiative.

The Critical Path Initiative was part of the FDA’s attempts to streamline and modernize the drug approval process by having companies pay user fees. Part of the Reagan-Udall Foundation’s responsibilities was to set goals and priorities for the Critical Path Initiative, and then award grants to meet those goals.

Massive Loophole: Nonprofits Funded by Industry

However, critics voiced concern, saying the Reagan-Udall Foundation might allow the food and medical industries “to sway FDA decisions,” since it could raise money from private, including industry, sources. To quell some of these fears, the Reagan-Udall Foundation said it would only accept grants from government, individual donors and other nonprofits, not industry.

After a few years of scraping by on small, private donations, the foundation received a $150,000 grant from the PhRMA Foundation, another nonprofit foundation funded by drug companies. Being a nonprofit, the PhRMA Foundation fit the description of an acceptable funding source, but just how independent can it actually be when it’s founded and funded by drug companies?

As noted by consumer advocate Sidney Wolfe with Public Citizen, while the PhRMA Foundation is technically a nonprofit, “one can hardly expect that they're going to do things that are not in the interests of their funders."⁴

Indeed, and this influence is in addition to the influence food, drug and medical device companies already have, by way of user fees. Again, the Prescription Drug User Fee Act established an accelerated application process for new drugs. The sped-up process is funded through industry-paid fees.

This fee, however, works more like a payoff or soft bribe. When a company pays the FDA for an accelerated review, the agency no longer has an incentive to find fault with the product or demand more extensive testing.

FDA Foundation Funded by the Gates Foundation

Not surprisingly, the Reagan-Udall Foundation has received large donations from the Bill & Melinda Gates Foundation, which we now know rarely does anything that doesn’t benefit Gates’ personal bottom line and overall agenda.

As detailed in “Bill Gates — Most Dangerous Philanthropist in Modern History?” Gates has used his philanthropy to shape public policy in ways that benefit his own agenda.

A March 17, 2020, article⁵ in The Nation titled, “Bill Gates’ Charity Paradox,” even points out that the Gates Foundation has given $2 billion in tax-deductible charitable donations to private companies, including GlaxoSmithKline, Unilever, IBM, Vodafone, the Mastercard affiliate MasterCard Labs for Financial Inclusion,^6,7 Scholastic Inc. and NBC Universal Media.^8,9  

Many of these so-called donations end up benefiting the Gates Foundation, as it also invests in the very same companies and industries that it donates money to. This circular economy is why Gates just keeps getting richer, the more money he gives away.

Part of this wealth growth also appears to be due to the tax breaks given for charitable donations. In short, it’s a perfect money-shuffling scheme that limits taxes while maximizing income generation.

If donating to for-profit companies sounds oddly illegal to you, you’d be right. Gates is a tax evader for doing so — he’s simply getting away with it. The nonprofit foundation is a disguise to avoid taxes while funding the research arms of for-profit organizations that his foundation is invested in, which is illegal.

The image below shows donations received by the Reagan-Udall Foundation in 2013. Topping the list is the Gates Foundation, whose contributions for the year amounted to $977,165, followed by a string of drug companies.

Board Members With Ties to Industry

In addition to all of this financial clout, food, drug and medical device makers also have the ability to exert influence over the FDA via the members¹⁰ of the Foundation board, and this was a concern right from the get-go.

As reported in the 2008 Journal of the National Cancer Institute article,¹¹ members of the then-newly created Reagan-Udall Foundation executive board had troubling ties to industry — and to the Gates Foundation, which years later (see above) ended up being a top financial donor. The article, written by Joel B. Finkelstein, reads, in part:¹²

“The Food and Drug Administration's most recent steps toward modernizing the drug approval process have renewed some old questions about the FDA's relationship with the industries it regulates.

Several public advocacy groups affiliated with physicians and researchers have voiced their concern over the appointment of certain members to a newly formed agency board. The groups have warned that some members may have conflicts of interest due to past or current roles as board members of pharmaceutical and biotechnology firms …

The [Reagan-Udall] foundation's board of directors, appointed by the FDA commissioner, will be largely responsible for establishing by-laws, selecting an executive director to oversee day-to-day operations, and reporting to Congress on foundation activities and operations.

The federal statute stipulates that of the 14 members named to the board, four members should come from industry, three from academia, two from consumer or patient advocacy organizations, and one from the health provider community. The remaining four spots are open to anyone with relevant expertise.

The FDA has already chosen the members and is organizing the Reagan–Udall Foundation. However, some advocacy groups are concerned that several nonindustry members have strong ties to pharmaceutical and biotechnology companies, including one who is currently under investigation by the Senate Finance Committee.

Tadataka ‘Tachi’ Yamada, M.D., currently heads the Bill and Melinda Gates Foundation's global health program but until 2006 worked as head of research for the pharmaceutical company GlaxoSmithKline.

Senate investigators have uncovered evidence suggesting that, during his tenure with the company, he may have been involved in an effort to intimidate a scientist who was raising questions about the heart risks associated with the company's blockbuster diabetes drug rosiglitazone maleate (Avandia).”

While the Reagan-Udall Foundation is the nonprofit arm of the FDA, the agency does not have the authority to set conflict-of-interest policies for the foundation.¹³ This, of course, leaves the door wide open for conflicts of interest and allows the Foundation to become a hidden back door of sorts, for corporate influence.

Industry Dictates Level of Evidence FDA Should Use

A more recent article,¹⁴ published in 2017 in The BMJ, points out that when the Reagan-Udall Foundation is using “big data” assess drug risks and device complications, they’re using “levels of evidence recommended by industry.” The potential for manipulation should be obvious. The article, written by BMJ associate editor Jeanne Lenzer, reads, in part:¹⁵

“Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety … However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).

The Reagan-Udall Foundation curates real world evidence or ‘big data’ derived from routinely collected health data from insurance claims, electronic health records, voluntary registries, and social media.

The U.S. drug and device regulator, the Food and Drug Administration, says that such data can speed up research, ‘saving time and money’ for ‘therapeutic development, outcomes research [and] safety surveillance.’

In January [2013], Robert Califf, then FDA commissioner, announced the launch of Innovation in Medical Evidence Development and Surveillance (IMEDS), a foundation project that he said would collect and analyze big data to identify ‘important safety issues.’

However, critics of the move say that big data are poor for identifying adverse events … Financial conflicts of interest, they worry, could influence the way big data are used, including exploitation of the weaknesses inherent in observational data to win FDA approval for new uses of drugs and devices and to exonerate drugs of previously detected harms. There is evidence and precedent to support both concerns.”

Lenzer also points out that the Foundation’s board of directors still has financial ties to the drug and device makers that the FDA is supposed to regulate. She notes that while no more than four of the 14-member board should be representatives of FDA regulated industries, in 2017, nine of the then 13-member board had financial ties to industry at the time of their appointment.

The Ties That Bind

To give just one example of how conflicts of interest can have real-world implications, take the case of Ellen V. Sigal, Ph.D.¹⁶ Sigal currently chairs the Reagan-Udall Foundation’s board of directors.¹⁷

She’s also vice president of the Cancer Moonshot program, and it too is funded by the Gates Foundation. Sigal’s colleague at the Cancer Moonshot Program, Dr. Doug Lowy, is a co-inventor of the HPV vaccine Gardasil, and Sigal’s son, David Sigal, is married to New York State Sen. Brad Hoylman, who recently sponsored a bill to make Gardasil mandatory for all school children in New York.

Hoylman is also supporting a bill that would allow children as young as 9 to receive the HPV vaccine at school without the knowledge or consent of their parents. Gates, of course, is also a supporter of HPV vaccination and funds HPV vaccine research.

Lastly, Sigal is on the board of the Parker Institute, which is partnered with a company called Inovio. Inovio, which is funded by the Gates Foundation, is working on a COVID-19 vaccine.

What are the chances Sigal’s son-in-law might support efforts to make the COVID-19 vaccine mandatory in New York as well? When you start tracing relationships, it’s amazing how often you find the Gates Foundation involved in matters relating to forced vaccinations and the destruction of legal protections.

FDA’s Lax Oversight of Clinical Research

Sad to say, it’s hard to find a government agency that hasn’t been captured by private interests. I’ve written several articles detailing the corruption at the CDC, for example, including “CDC Petitioned to Stop Lying About Pharma Funds,” “How Conflicts of Interest Have Corrupted the CDC” and “Public Health Agency Sued for Coke Collusion.”

The same can be said about the World Health Organization which, of course, is also funded by the Gates Foundation. In fact, when the U.S. withdrew its funding, Gates stepped in and became the largest funder — larger even than entire nations.

Without doubt, the FDA can be added to the list of agencies that largely serves corporate masters, hidden as they may be behind nonprofit façades. A recent investigative report¹⁸ by Science Magazine highlights the agency’s failures when it comes to overseeing clinical research, which is one of its many duties.

Inspectors conduct routine visits to research trial sites and review trial records to make sure research parameters and safety protocols are followed. They also respond to complaints by whistleblowers.

However, FDA documents obtained via Freedom of Information Act (FOIA) requests reveal it rarely sanctions or penalizes researchers or research companies even when grave problems — including fraud — are found. What’s more, there’s a marked trend toward less and less adequate oversight.

Case in point: Aspen Clinical Research, run by Dr. Michael Harris, has on numerous occasions over the past decade been cited for “egregious errors” in its clinical trials, yet the FDA never followed through on its threats to fine, prosecute or disqualify Harris from conducting clinical research in the U.S. According to the report, written by Charles Piller:¹⁹

“FDA found there were serious lapses in obtaining informed consent from trial volunteers, unqualified staff made medical assessments, and Harris failed to properly report abnormal lab test results. He also did not disclose that trial participants were taking opioid, antidepressant, or antipsychotic drugs — which could have skewed results or posed safety concerns.

The agency said Aspen’s records were disorganized, contradictory, and sometimes backdated in a way that ‘begs the question of the authenticity and veracity of data collected.’ Those ‘serious, ongoing deviations’ might constitute ‘fraud, scientific misconduct,’ and ‘significant human subject protection violations,’ according to FDA documents …

Repeat problems and a raft of new ones emerged during inspections in 2014, 2015, and 2019. Each time, in responses to FDA, Harris admitted some transgressions, strenuously disputed others, and promised to improve.

Through all that, FDA never formally sanctioned Harris or pursued other penalties. The agency never made public the alleged offenses or told trial participants they might have been put at risk. Nor did it tell companies sponsoring some of the trials that their data might have been compromised …

Meanwhile, pharmaceutical and medical device companies continued to contract with Aspen. Since 2011, they have paid the firm millions of dollars for work on at least 65 trials, and Aspen is now recruiting people for nine new trials on Alzheimer’s disease, autism, depression, and other serious disorders.”

According to Piller, this isn’t a rare case. After reviewing some 1,600 FDA inspection and enforcement documents, Piller’s conclusion is that the “FDA’s enforcement of clinical research regulations is often light-handed, slow-moving, and secretive.”

“Clear corrections of inspector-reported dangerous or unlawful clinical trial practices were the exception, even amid signs that trial participants were harmed and that data underpinning evidence-based medicine were corrupted,” Piller writes.

“On the rare occasions when FDA formally warned researchers of findings that they had broken the law, the agency often neglected to ensure that fixes occurred … Moreover, the agency frequently closed cases on the basis of unverified claims by those accused.”

I recommend reading Piller’s report in its entirety. It’s a sobering read that raises all sorts of questions about drug safety.

If a drug trial is riddled with errors, omissions and outright fraud and falsification of documents and data — examples of which are given in Piller’s report — and this research is then used to gain FDA approval, the chances of that drug being harmful can be considerable. Clearly, oversight without follow-up and follow-through when problems are found is about as useful as no oversight at all.

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