“THEY” Do Not Want an Effective and Inexpensive Treatment -No $$$ For Them

An Effective COVID Treatment the Media Continues to Besmirch

August 04, 2020

An Effective COVID Treatment the Media Continues to Besmirch
(AP Photo/Rafiq Maqbool)

On Friday, July 31, in a column ostensibly dealing with health care “misinformation,” Washington Post media critic Margaret Sullivan opened by lambasting “fringe doctors spouting dangerous falsehoods about hydroxychloroquine as a COVID-19 wonder cure.”

Actually, it was Sullivan who was spouting dangerous falsehoods about this drug, something the Washington Post and much of the rest of the media have been doing for months. On May 15, the Post offered a stark warning to any Americans who may have taken hope in a possible therapy for COVID-19. In the newspaper’s telling, there was nothing unambiguous about the science — or the politics — of hydroxychloroquine: “Drug promoted by Trump as coronavirus game-changer increasingly linked to deaths,” blared the headline. Written by three Post staff writers, the story asserted that the effectiveness of hydroxychloroquine in treating COVID-19 is scant and that the drug is inherently unsafe.

This claim is nonsense

Biased against the use of hydroxychloroquine for COVID-19 — and the Washington Post is hardly alone — the paper described an April 21, 2020, drug study on U.S. Veterans Affairs patients hospitalized with the illness. It found a high death rate in patients taking the drug hydroxychloroquine. But this was a flawed study with a small sample, the main flaw being that the drug was given to the sickest patients who were already dying because of their age and severe pre-existing conditions. This study was quickly debunked. It had been posted on a non-peer-reviewed medical archive that specifically warns that studies posted on its website should not be reported in the media as established information.

Yet, the Post and countless other news outlets did just the opposite, making repeated claims that hydroxychloroquine was ineffective and caused serious cardiac problems. Nowhere was there any mention of the fact that COVID-19 damages the heart during infection, sometimes causing irregular and sometimes fatal heart rhythms in patients not taking the drug.

To a media unrelentingly hostile to Donald Trump, this meant that the president could be portrayed as recklessly promoting the use of a “dangerous” drug. Ignoring the refutation of the VA study in its May 15 article, the Washington Post cited a Brazil study published on April 24 in which a COVID trial using chloroquine (a related but different drug than hydroxychloroquine) was stopped because 11 patients treated with it died. The reporters never mentioned another problem with that study: The Brazilian doctors were giving their patients lethal cumulative doses of the drug.

On and on it has gone since then, in a circle of self-reinforcing commentary. Following the news that Trump was taking the drug himself, opinion hosts on cable news channels launched continual attacks on both hydroxychloroquine and the president. “This will kill you!” Fox News Channel’s Neil Cavuto exclaimed. “The president of the United States just acknowledge that he is taking hydroxychloroquine, a drug that [was] meant really to treat malaria and lupus.”

Washington Post reporters Ariana Cha and Laurie McGinley were back again on May 22, with a new article shouting out the new supposed news: “Antimalarial drug touted by President Trump is linked to increased risk of death in coronavirus patients, study says.” The media uproar this time was based on a large study just published in the Lancet. There was just one problem. The Lancet paper was fraudulent and it was quickly retracted.

However, the damage from the biased media storm was done and it was long-lasting. Continuing patient enrollment needed for early-use clinical trials of hydroxychloroquine dried up within a week. Patients were afraid to take the drug, doctors became afraid to prescribe it, pharmacies refused to fill prescriptions, and in a rush of incompetent analysis and non-existent senior leadership, the FDA revoked its Emergency Use Authorization for the drug.

So what is the real story on hydroxychloroquine? Here, briefly, is what we know:

When the COVID-19 pandemic began, a search was made for suitable antiviral therapies to use as treatment until a vaccine could be produced. One drug, hydroxychloroquine, was found to be the most effective and safe for use against the virus. Federal funds were used for clinical trials of it, but there was no guidance from Dr. Anthony Fauci or the NIH Treatment Guidelines Panel on what role the drug would play in the national pandemic response. Fauci seemed to be unaware that there actually was a national pandemic plan for respiratory viruses.

Following a careful regimen developed by doctors in France, some knowledgeable practicing U.S. physicians began prescribing hydroxychloroquine to patients still in the early phase of COVID infection. Its effects seemed dramatic. Patients still became sick, but for the most part they avoided hospitalization. In contrast — and in error — the NIH-funded studies somehow became focused on giving hydroxychloroquine to late-presenting hospitalized patients. This was in spite of the fact that unlike the drug’s early use in ambulatory patients, there was no real data to support the drug’s use in more severe hospitalized patients.

By April, it was clear that roughly seven days from the time of the first onset of symptoms, a COVID-19 infection could sometimes progress into a more radical late phase of severe disease with inflammation of the blood vessels in the body and immune system over-reactions. Many patients developed blood clots in their lungs and needed mechanical ventilation. Some needed kidney dialysis. In light of this pathological carnage, no antiviral drug could be expected to show much of an effect during this severe second stage of COVID.

On April 6, 2020, an international team of medical experts published an extensive study of hydroxychloroquine in more than 130,000 patients with connective tissue disorders. They reaffirmed that hydroxychloroquine was a safe drug with no serious side effects. The drug could safely be given to pregnant women and breast-feeding mothers. Consequently, countries such as China, Turkey, South Korea, India, Morocco, Algeria, and others began to use hydroxychloroquine widely and early in their national pandemic response. Doctors overseas were safely prescribing the drug based on clinical signs and symptoms because widespread testing was not available.

However, the NIH promoted a much different strategy for the United States. The “Fauci Strategy” was to keep early infected patients quarantined at home without treatment until they developed a shortness of breath and had to be admitted to a hospital. Then they would they be given hydroxychloroquine. The Food and Drug Administration cluelessly agreed to this doctrine and it stated in its hydroxychloroquine Emergency Use Authorization (EUA) that “hospitalized patients were likely to have a greater prospect of benefit (compared to ambulatory patients with mild illness).”

In reality just the opposite was true. This was a tragic mistake by Fauci and FDA Commissioner Dr. Stephen Hahn and it was a mistake that would cost the lives of thousands of Americans in the days to come.

At the same time, accumulating data showed remarkable results if hydroxychloroquine were given to patients early, during a seven-day window from the time of first symptom onset. If given during this window, most infections did not progress into the severe, lethal second stage of the disease. Patients still got sick, but they avoided hospitalization or the later transfer to an intensive care unit. In mid-April a high-level memo was sent to the FDA alerting them to the fact that the best use for hydroxychloroquine was for its early use in still ambulatory COVID patients. These patients were quarantined at home but were not short of breath and did not yet require supplemental oxygen and hospitalization.

Failing to understand that COVID-19 could be a two-stage disease process, the FDA ignored the memo and, as previously mentioned, it withdrew its EUA for hydroxychloroquine based on flawed studies and clinical trials that were applicable only to late-stage COVID patients.

By now, however, some countries had already implemented early, aggressive, outpatient community treatment with hydroxychloroquine and within weeks were able to minimize their COVID deaths and bring their national pandemic under some degree of control.

In countries such as Great Britain and the United States, where the “Fauci-Hahn Strategy” was followed, there was a much higher death rate and an ever-increasing number of cases. COVID patients in the U.S. would continue to be quarantined at home and left untreated until they developed shortness of breath. Then they would be admitted to the hospital and given hydroxychloroquine outside the narrow window for the drug’s maximum effectiveness.

In further contrast, countries that started out with the “Fauci-Hahn Doctrine” and then later shifted their policy towards aggressive outpatient hydroxychloroquine use, after a brief lag period also saw a stunning rapid reduction in COVID mortality and hospital admissions.

Finally, several nations that had started using an aggressive early-use outpatient policy for hydroxychloroquine, including France and Switzerland, stopped this practice when the WHO temporarily withdrew its support for the drug. Five days after the publication of the fake Lancet study and the resulting media onslaught, Swiss politicians banned hydroxychloroquine use in the country from May  27 until June 11, when it was quickly reinstated.

The consequences of suddenly stopping hydroxychloroquine can be seen by examining a graph of the Case Fatality Ratio Index (nrCFR) for Switzerland. This is derived by dividing the number of daily new COVID fatalities by the new cases resolved over a period with a seven-day moving average. Looking at the evolution curve of the CFR it can be seen that during the weeks preceding the ban on hydroxychloroquine, the nrCFR index fluctuated between 3% and 5%.

Following a lag of 13 days after stopping outpatient hydroxychloroquine use, the country’s COVID-19 deaths increased four-fold and the nrCFR index stayed elevated at the highest level it had been since early in the COVID pandemic, oscillating at over 10%-15%. Early outpatient hydroxychloroquine was restarted June 11 but the four-fold “wave of excess lethality” lasted until June 22, after which the nrCFR rapidly returned to its background value.

Here in our country, Fauci continued to ignore the ever accumulating and remarkable early-use data on hydroxychloroquine and he became focused on a new antiviral compound named remdesivir. This was an experimental drug that had to be given intravenously every day for five days. It was never suitable for major widespread outpatient or at-home use as part of a national pandemic plan. We now know now that remdesivir has no effect on overall COVID patient mortality and it costs thousands of dollars per patient.

Hydroxychloroquine, by contrast, costs 60 cents a tablet, it can be taken at home, it fits in with the national pandemic plan for respiratory viruses, and a course of therapy simply requires swallowing three tablets in the first 24 hours followed by one tablet every 12 hours for five days.

There are now 53 studies that show positive results of hydroxychloroquine in COVID infections. There are 14 global studies that show neutral or negative results — and 10 of them were of patients in very late stages of COVID-19, where no antiviral drug can be expected to have much effect. Of the remaining four studies, two come from the same University of Minnesota author. The other two are from the faulty Brazil paper, which should be retracted, and the fake Lancet paper, which was.

Millions of people are taking or have taken hydroxychloroquine in nations that have managed to get their national pandemic under some degree of control. Two recent, large, early-use clinical trials have been conducted by the Henry Ford Health System and at Mount Sinai showing a 51% and 47% lower mortality, respectively, in hospitalized patients given hydroxychloroquine. A recent study from Spain published on July 29, two days before Margaret Sullivan’s strafing of “fringe doctors,” shows a 66% reduction in COVID mortality in patients taking hydroxychloroquine. No serious side effects were reported in these studies and no epidemic of heartbeat abnormalities.

This is ground-shaking news. Why is it not being widely reported? Why is the American media trying to run the U.S. pandemic response with its own misinformation?

Steven Hatfill is a veteran virologist who helped establish the Rapid Hemorrhagic Fever Response Teams for the National Medical Disaster Unit in Kenya, Africa. He is an adjunct assistant professor in two departments at the George Washington University Medical Center where he teaches mass casualty medicine. He is principle author of the prophetic book “Three Seconds Until Midnight — Preparing for the Next Pandemic,” published by Amazon in 2019.

from:    https://www.realclearpolitics.com/articles/2020/08/04/an_effective_covid_treatment_the_media_continues_to_besmirch_143875.html

Stand Up For Personal Health Freedom

Hydroxychloroquine, COVID, FDA; and Pharma and all its whores around the world

by Jon Rappoport

July 29, 2020

(To join our email list, click here.)

“We are talking about private contracts outside the scope of government. We’re talking about local barter, and the issuing of local currencies, the building of private money systems. During the Great Depression, many citizens looked around and said, ‘We still have land and food, we still have commodities. Nothing has changed here. We just have to invent a way to conduct commerce among ourselves.’ One estimate states that, during the Depression of the 1930s, there were 1500 private money systems across America.” (My notes for “The Underground”)

I have made my case concerning the fake pandemic. Many times now.

From the beginning—the failure to isolate, purify, or actually discover a novel coronavirus by correct procedures. The meaningless diagnostic tests and the meaningless case numbers. The propaganda. The use of “the virus” as a cover story obscuring high-level corporate and government crimes.

Of course, many people believe in the COVID-19 virus. And of these, some have been seeking treatments outside the bounds of government certification.

This is their right. They are exercising freedom in managing their own health. And so some of them are taking hydroxychloroquine (HCQ).

The FDA, which certifies all medical drugs as safe and effective, before they are released for public use, has not recommended HCQ for COVID treatment. It has banned the drug for that purpose, outside of hospitals and clinical trials.

The FDA‘s track record—which I’ve been documenting for the past 25 years—is a horror show. The first key review I became aware of was authored in 2000, by Dr. Barbara Starfield, and published on July 26th of that year, in the Journal of the American Medical Association. Starfield stated that, annually, FDA-approved medicines kill 106,000 Americans. That’s over a million Americans per decade. So relying on the FDA to decide whether HCQ is a useful drug is not a concession some Americans are willing to make.

Pharma and all its allies and minions and whores are focusing on a jackpot bonanza for COVID treatment: vaccines and new antiviral drugs. Pharma does not want competition. It definitely does not want to see a landscape in which all sorts of alternative treatments for COVID (or any purported disease) are rampant and free-wheeling.

We are seeing multiple censorship actions across platforms, when people, including doctors, speak positively about HCQ.

Fauci is very much in the pro-Pharma camp, of course. He and Gates want an RNA vaccine to come to market, by any means necessary. They also want antiviral drugs to dominate COVID treatment.

A very sharp reader spelled out the Pharma-anticipated future for these new (toxic) antiviral medicines. And not just for COVID. Up to now, there has been very little mainstream progress in getting drugs specifically designed to treat viruses into the marketplace. This is Pharma’s big opportunity. They envision a trillion-dollar operation that will elevate antivirals (for treating any viruses) to the level of, say, antibiotics, which are used against bacteria. COVID would simply be the first major “breakthrough.”

So we have a war going on. HCQ and other alternative modalities vs. vaccines and antivirals. Pharma does not want to lose this one. It would be disastrous.

I am not touting HCQ. I am putting it this way: if many people are convinced, or become convinced, that HCQ is a drug of choice, and if they believe it is helping them, then a major rebellion against Pharma and the FDA and its counterparts around the world takes off. It soars. And it spurs the use of other alternatives on which Pharma makes zero profits.

So-called natural health and alternative medicine have been booming since the 1980s. A new escalation would send very serious shock waves through the pharmaceutical industry.

Fauci is well aware of this. He is fronting for the industry in every possible way. Trump, with his statements favoring HCQ, has become a major threat in that regard.

When you see new reports of soaring COVID case numbers—a con which I’ve documented six ways from Sunday—you’re not only witnessing a planned strategy to maintain the war against the economy and therefore against billions of people whose lives are at stake; you’re also watching a justification for pushing antivirals and vaccines. For the benefit of Pharma.

The last thing the pharmaceutical industry wants to see is their own case-number con giving birth to wildcat outbreaks of health freedom. People leaving the nest. People going elsewhere for treatment.

Individuals making decisions about their own treatments—this is very serious business. People should look deeply before making choices. In the case of various HCQ protocols, they should consider: dosage levels; when in the course of illness the drug would be given (early or late); whether there is illness requiring treatment to begin with; whether people may have a heredity condition which could make HCQ perilous or even lethal—these are some of the relevant considerations.

The FDA and Pharma want to be the first and last word.

Life and Liberty say they are not the first and last word.

In that regard, there is another issue: licenses vs. contracts. The medical cartel, backed by governments, has established medical boards which grant licenses to practice medicine. These special persons, doctors, are handed the right to treat and cure diseases. This is an attempt to create a monopoly.

There is another avenue: private contracts. Here is the analogy I’ve used to describe this situation. Two adults, Joe and Fred, enter into an agreement. Joe says he has a health condition. He will be the patient. Fred will be the practitioner. Fred has a well on his property. Fred believes the water has a special healing quality. He will give some of it (or sell it) to Joe, who will drink it over the course of two weeks.

Both men, in their contract, agree that no legal liability will be attached to the outcome. They are both responsible. They are of sound mind. They don’t require government permission to sign or fulfill their contract.

That’s it in a nutshell.

Joe and Fred are operating on their own. They have that natural right. They also have the right to be wrong—in case the water treatment doesn’t work, or is harmful.

Of course, all sorts of meddlers will claim this arrangement is illegal and absurd. Meddlers always try to curb freedom. That’s their crusade in life. They can’t stand the idea of people making their own choices and decisions and then accepting the consequences.

I’m not saying governments will honor such contracts. Governments are prime meddlers. I’m saying these contracts (and not just in the arena of healing) stand outside governments. They are citizen-to-citizen. They are prior to government. They are intrinsically more real than government.

from:    https://blog.nomorefakenews.com/2020/07/30/hcq-covid-fda-and-pharma-and-all-its-whores/

Drugs, Efficacy, & Safety


Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds

Date:
August 17, 2010
Source:
American Sociological Association

The pharmaceutical industry is a “market for lemons,” a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.

“Sometimes drug companies hide or downplay information about serious side effects of new drugs and overstate the drugs’ benefits,” said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. “Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It’s really a two-tier market for lemons.”

Three reasons why the pharmaceutical market produces “lemons” are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.

According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, toxic side effects or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.

Light’s paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” is an institutional analysis of the pharmaceutical industry and how it works based on a range of independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the Food and Drug Administration, and Prescrire International.

The foundation for the paper is the work Light did for a forthcoming book he edited, titled ‘The Risk of Prescription Drugs,” which is scheduled for publication this fall by Columbia University Press.

In both his paper and his book, Light describes the “Risk Proliferation Syndrome” that is maximizing the number of patients exposed to new drugs that have relatively low efficacy and effectiveness but have greater risk of adverse side effects. Building on clinical trials designed to minimize evidence of harm and published literature that emphasizes a drug’s advantages, companies launch massive campaigns to sell it, when a controlled, limited launch would allow evidence to be gathered about the drug’s effects. Companies recruit leading clinicians to try using the drug for conditions other than those for which it is approved and to promote such off-label or unapproved uses. Physicians inadvertently become “double agents” — promoters of the new drug, yet trusted stewards of patients’ well-being, said Light. When patients complain of adverse reactions, studies show their doctors are likely to discount or dismiss them, according to Light.

Despite the extensive requirements for testing the efficacy and safety of each new drug, companies “swamp the regulator” with large numbers of incomplete, partial, substandard clinical trials, Light said. For example, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects, said Light.

“Just recently, major reports have come out about biased, poor trials for Avandia and Avastin,” Light said, who noted that orphan drugs are tested even less well.

“The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause,” Light said. The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published.

“A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs,” Light said. “We could also increase the percentage of new drugs that are really better for patients.”

The paper, “Pharmaceuticals: A Two-Tier Market for Producing ‘Lemons’ and Serious Harm,” was presented on Aug. 17 in Atlanta at the American Sociological Association’s 105th Annual Meeting.

Story Source:

Materials provided by American Sociological Association. Note: Content may be edited for style and length.

from:    https://www.sciencedaily.com/releases/2010/08/100817111825.htm

American Sociological Association. “Pharmaceuticals: A market for producing ‘lemons’ and serious harm, analysis finds.” ScienceDaily. ScienceDaily, 17 August 2010. <www.sciencedaily.com/releases/2010/08/100817111825.htm>.

Drugs – Safety, Profitability, etc.

Serious Risks And Few New Benefits From FDA-Approved Drugs

Over the past year, the U.S. Senate and The New York Times have been investigating the failure of the nation’s auto safety regulators to protect citizens from cars with occasionally dangerous faulty devices.

But neither august institution has paid attention to the Food and Drug Administration’s (FDA) failure to protect the 170 million Americans who take prescription drugs from adverse reactions that are killing more than 2,400 people every week. Annually, prescription drugs cause over 81 million adverse reactions and result in 2.7 million hospitalizations.

This epidemic of harm from medications makes our prescription drugs the fourth leading cause of death in the United States. Including hospitalizations and deaths from prescribing errors, overdosing, and self-medication, drugs move up to third place.

Below I describe the biases that appear throughout the drug development process, from initial research to FDA review and approval. I conclude with recommendations that would reduce drug development costs and ensure that drugs are only approved if they are safe and significantly more effective than already existing medications.

A Me-Too Business Model

Every drug has risks, so any drug considered for FDA approval should demonstrate clinical advantages that justify those risks. Yet public, independent advisory teams of physicians and pharmacists in several countries found over 90 percent of new drugs approved by the FDA and the European Medicines Agency (EMA) offer few or no advantages over existing drugs to offset their risks of serious harm.

Figure 1 shows the scorecard for 979 newly approved drugs over a 10-year span, based on detailed assessment of clinical benefits and risks by Prescrire, one of the world’s most distinguished, independent review bodies of physicians and pharmacists. (The exhibit focuses on France, a country whose consumer-oriented drug market features an array of products similar to the U.S.)

Figure 1. Few Clinical Advances in a Decade and Hundreds of Other Drugs Approved for Promotion

Light-Figure 1

Only two were breakthrough advances and fewer than 10 percent offered substantial clinical advantages over existing drugs. Yet approved drugs have a 20 percent risk of producing enough harm for regulators to add a serious warning or have them withdrawn.

Flooding the market with hundreds of minor variations on existing drugs and technically innovative but clinically inconsequential new drugs, appears to be the de facto hidden business model of drug companies. In spite of its primary charge to protect the public, the FDA criteria for approval encourage that business model. The main products of pharmaceutical research are scores of clinically minor drugs that win patent protection for high prices, with only a few clinically important advances like Sovaldi or Gleevec.

This business model works. Despite producing drugs with few clinical advantages and significant health risks, industry sales and profits have grown substantially, at public expense. Companies spend 2-3 times less on research than on marketing to convince physicians to prescribe these minor variations.

Industry figures show the public pays companies about six times R&D costs through high prices on drugs. According to a study by Consumer Reports, high costs to patients lead them to postpone visits to physicians, avoid medical tests, and be able unable to afford other, effective drugs. For society as a whole, a leading health economist found that 80 percent of all new expenditures for drugs was spent on the minor variations, not the major advances.

Institutional Corruption

These startling results reflect studies from the Edmond J. Safra Center for Ethics at Harvard University, where research fellows have investigated “institutional corruption” in the pharmaceutical industry. “Institutional corruption” refers to systemic, legal ways that social institutions such as medical science, the medical profession, and the FDA become compromised by corporate and special-interest funding and influence.

Peer-reviewed studies already demonstrate how pharmaceutical companies manipulate FDA rules to generate evidence that their new drugs are more effective and less harmful than unbiased studies would show. The industry then recruits teams of medical writers, editors, and statisticians to select and repackage trial results into peer-reviewed articles that become accepted as reliable medical knowledge.

Based on his investigations, Marc Rodwin concludes, “Scholarly studies have revealed that drug firms design trials that skew the results and that they distort the evidence by selective reporting or biased interpretation.” This distorted evidence goes into clinical guidelines that become, Lisa Cosgrove and Emily Wheeler note, “essentially marketing tools for drug companies.”

Often Neither Safe Nor Effective

The Center for Drug Evaluation and Research (CDER – pronounced “C-DER”) is the FDA division responsible for determining whether new drugs should be approved. Its funding, however, now largely comes not from taxpayers but from the companies submitting their drugs to CDER for review.

This clear conflict of interest and approving so many new drugs with few clinical benefits serve corporate interests more than public interests, especially given the large risks of serious harm. Direct and indirect costs to society far exceed the cost of funding the FDA as a public, independent review body.

New FDA policies to get more drugs reviewed faster so that they can reach patients sooner result ironically in even more drugs being approved with less evidence that they are either safer or more effective. Faster reviews mean the chance that a drug will generate an FDA warning of serious harm jumps from one in five to one in three.

A systematic study of shortened reviews found that each 10-month reduction in review time produced an 18 percent increase of serious adverse reactions, an 11 percent increase of drug-related hospitalizations, and a 7.2 percent increase of drug-related deaths. Only 72 out of 1,300 CDER staff are charged with investigating drug safety, hard evidence that drug safety is a low priority at the FDA.

A recent review of FDA policies in Health Affairs describes how the FDA creates initiatives that ostensibly demonstrate its concern for safety from faster approvals. But the authors then describe how these initiatives frequently fail or backfire. They report no evidence of reduced harm or improved benefit to patients receiving these expedited drugs.

People imagine the FDA has stringent standards that take months or sometimes years for companies to meet. To a degree, that’s true. But the external independent evidence cited here of few new benefits and substantial risks of harm, calls into question what all this costly, lengthy review process is about.

An anthropologist might conclude it’s an elaborate ritual to make the FDA look like a tough watchdog against unsafe and ineffective drugs while it’s an industry-funded lapdog. Consider the easy ride that the FDA gives cancer drugs, requiring little evidence of improved patient outcomes.

For example, approving that new drugs are better than placebo is a low standard when other effective drugs already exist. Placebo trials are also unethical in these situations because they deny subjects in the control arm the use of an effective drug.

Another FDA standard, to prove that approved drugs are “non-inferior,” or not too much worse than an existing drug, does not allow patients to know if the new drug is better than the one they are taking. Using substitute measures for real benefits to patients makes approved drugs look more effective than they are. Allowing randomized trials to be drawn from biased populations that exclude many people who are likely to take the drug and experience an adverse reaction makes new drugs appear safer than they are.

Why does the FDA allow paymasters to design such trials?

Failure To Warn

The FDA is charged with providing physicians and the public with objective, scientific evidence showing that new drugs are safe and effective. Conveniently for drug companies, it carries out this responsibility narrowly by focusing on the label and not on alerting physicians or the public about biased evidence from those trials in leading medical journals that go into guidelines.

The FDA could alert the profession and public about how end points and other details get switched by industry ghost-writing teams, about unpublished negative results, and about positive results published twice; but it does not. Ghost writing and the ghost management of medical knowledge thrive.

To protect the public from unsafe and ineffective drugs and earn public trust, the FDA and Congress must acknowledge the biases described here that result from pharmaceutical corporations financing the public regulator. They should also require two changes: that new drugs demonstrate patient-based clinical advantages through comparative trials, and that these trials be based on the population that will actually take a drug.

These changes would reduce the flood of minor variations shown in Exhibit 1 and the subsequent billions spent on them.

from:    https://www.healthaffairs.org/do/10.1377/hblog20150706.049097/full/

Adult Stem Cell Therapy & the FDA

How Safe is the Impossible Burger?

WASHINGTON, D.C. – Creators of a fake-meat burger made with a high-profile genetically engineered ingredient may have landed their experimental industry in a sizzling food safety mess, casting doubt on a Silicon Valley foodtech investor bubble.

As reported on in today’s New York Times, recently obtained documents from the U.S. Food and Drug Administration (FDA) reveal that Impossible Foods, maker of the Impossible Burger, the meatless burger that supposedly “bleeds,” was told by FDA officials that it hadn’t provided adequate proof of safety for a genetically engineered protein that gives the burger its meat-like taste and color. Impossible Foods put the genetically engineered product on the market for public consumption even though the company privately admitted to the FDA that it had not conducted or designed safety tests. The FOIA-produced documents state that the “FDA believes that the arguments presented, individually and collectively, do not establish the safety of SLH for consumption, nor do they point to a general recognition of safety.”

“The FDA told Impossible Foods that its burger was not going to meet government safety standards, and the company admitted it didn’t know all of its constituents. Yet it sold it anyway to thousands of unwitting consumers. Responsible food companies don’t treat customers this way,” said Jim Thomas of ETC Group. “Impossible Foods should pull the burgers from the market unless and until safety can be established by the FDA and apologize to those whose safety it may have risked.”

“Under no circumstances should any food company ignore FDA safety warnings and put consumers’ health at risk,” Dana Perls, senior food and technology campaigner at Friends of the Earth. “The FDA must be the authority when it comes to determining food safety, and that means overhauling the broken regulatory process so that companies like Impossible Foods cannot self-regulate and rubber stamp their products as safe.”

The FDA’s safety designation of “generally recognized as safe” (GRAS) allows a manufacturer, like Impossible Foods, to decide for itself, without FDA input, whether or not a product is safe. The self-determination does not require notice to the public or the FDA, and may apply to food chemicals regardless of industry conflicts of interest, or whether the chemicals are new or not widely studied.

U.S. government documents, obtained by ETC Group and Friends of the Earth U.S. through the Freedom of Information Act, reveal that Impossible Foods was warned by FDA officials that its key genetically engineered ingredient, “soy leghemeglobin” (SLH), would not meet the basic FDA GRAS status. SLH, or “heme,” is a bio-engineered protein additive that adds meat-like taste and color. Impossible Foods recognizes that SLH has never been widespread in the human diet in its natural or genetically engineered form. Despite touting the color properties of the engineered “heme,” Impossible Foods did not seek FDA approval as a color additive, which has stricter safety regulations.

In discussion with FDA, Impossible Foods also admitted that up to a quarter of its “heme” ingredient was composed of 46 “unexpected” additional proteins, some of which are unidentified and none of which were assessed for safety in the dossier.

The case of Impossible Burger raises concerns that surpass this one patty and implicates the extreme genetic engineering field of synthetic biology, particularly the new high-tech investor trend of “vat-itarian” foods (meat, dairy, and other animal proteins grown in a biotech vat instead of from an animal). While Impossible Burger is the poster child for this vat-grown approach, other companies such as Perfect Day (synthetic biology cow milk) and Clara Foods (synthetic biology egg whites) appear also to be racing to market. Just as biofuels were pitched as a “clean tech” fix to climate change a decade ago, the vat-itarian venture capitalists are now attempting to capitalize on animal welfare concerns through “molecular farming.”

While the health and environmental damage caused by large-scale industrial livestock production should not be minimized, the success of non-animal burgers like the non-GMO Beyond Burger demonstrates that plant-based animal substitutes can succeed without resorting to genetic engineering.

A 2013 US National Survey by Hart Research found that 61% of respondents felt negative about synthetic biology-produced food additives. Polls also show that consumers increasingly want GMOs to be labeled as such, but so far, most companies selling products with synthetic biology ingredients, including Impossible Foods, are not labeling on the products or menus.

Friends of the Earth and ETC Group reached out last week to Impossible Foods, inviting the company to a discussion on the safety of the Impossible Burger.

###

Impossible Burger FOIA documents are available here.

For further information and analysis see ETC Group’s on-line searchable database of synthetic biology derived ingredients, including Impossible Food’s “heme”.

See Friends of the Earth’s blog on synthetic biology animal replacement products “Is ‘Food-Tech’ the Future of Food?” and website for additional information on synthetic biology’s risks to our health and environment.

from:    http://www.synbiowatch.org/2017/08/bleeding-veggie-burger-has-no-basis-for-safety-according-to-fda/?lores

Walnuts – Who Knew!

by MICHAEL TENNANT

Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.

Diamond’s transgression was to make “financial investments to educate the public and supply them with walnuts,” as William Faloon of Life Extension magazine put it. On its website and packaging, the company stated that the omega-3 fatty acids found in walnuts have been shown to have certain health benefits, including reduced risk of heart disease and some types of cancer. These claims, Faloon notes, are well supported by scientific research: “Life Extension has published 57 articles that describe the health benefits of walnuts”; and “The US National Library of Medicine database contains no fewer than 35 peer-reviewed published papers supporting a claim that ingesting walnuts improves vascular health and may reduce heart attack risk.”

This evidence was apparently not good enough for the FDA, which told Diamond that its walnuts were “misbranded” because the “product bears health claims that are not authorized by the FDA.”

The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?

“The FDA’s language,” Faloon writes, “resembles that of an out-of-control police state where tyranny [reigns] over rationality.” He adds:

This kind of bureaucratic tyranny sends a strong signal to the food industry not to innovate in a way that informs the public about foods that protect against disease. While consumers increasingly reach for healthier dietary choices, the federal government wants to deny food companies the ability to convey findings from scientific studies about their products.

Walnuts aren’t the only food whose health benefits the FDA has tried to suppress. Producers of pomegranate juice and green tea, among others, have felt the bureaucrats’ wrath whenever they have suggested that their products are good for people.

Meanwhile, Faloon points out, foods that have little to no redeeming value are advertised endlessly, often with dubious health claims attached. For example, Frito-Lay is permitted to make all kinds of claims about its fat-laden, fried products, including that Lay’s potato chips are “heart healthy.” Faloon concludes that “the FDA obviously does not want the public to discover that they can reduce their risk of age-related disease by consuming healthy foods. They prefer consumers only learn about mass-marketed garbage foods that shorten life span by increasing degenerative disease risk.”

Faloon thinks he knows why this is the case. First, by stifling competition from makers of more healthful alternatives, junk food manufacturers, who he says “heavily lobb[y]” the federal government for favorable treatment, will rake in ever greater profits. Second, by making it less likely that Americans will consume healthful foods, big pharmaceutical companies and medical device manufacturers stand to gain by selling more “expensive cardiac drugs, stents, and coronary bypass procedures” to those made ill by their diets.

But people are starting to fight back against the FDA’s tactics. “The makers of pomegranate juice, for example, have sued the FTC for censoring their First Amendment right to communicate scientific information to the public,” Faloon reports. Congress is also getting into the act with a bill, the Free Speech About Science Act (H.R. 1364), that, Faloon writes, “protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.”

Of course, if the Constitution were being followed as intended, none of this would be necessary. The FDA would not exist; but if it did, as a creation of Congress it would have no power to censor any speech whatsoever. If companies are making false claims about their products, the market will quickly punish them for it, and genuine fraud can be handled through the courts. In the absence of a government agency supposedly guaranteeing the safety of their food and drugs and the truthfulness of producers’ claims, consumers would become more discerning, as indeed they already are becoming despite the FDA’s attempts to prevent the dissemination of scientific research. Besides, as Faloon observed, “If anyone still thinks that federal agencies like the FDA protect the public, this proclamation that healthy foods are illegal drugs exposes the government’s sordid charade.”

Source: The New American – Like The New American on facebook

from:    http://www.realfarmacy.com/walnuts-are-drugs-says-fda/

FDA Targeting Essential Oils?

FDA sends warning letters to Essential Oil Companies, Young Living and doTERRA!

Oct 2

essential oil fdaEssential oils are used in aromatherapy and may provide numerous health benefits.  These oils are starting to be explored by the scientific community for their effectiveness in treating cancer, HIV, asthma, bronchitis, heart disease and strokes. (1)
It appears that the FDA is not too happy about this healing potential.  This past week, Young Living and doTERRA both received letters from the FDA claiming that their products are being marketed as unapproved drugs.  The companies are being told that they have to remove all health claims and take corrective actions or they face serious legal consequences.  Considering past FDA threats, these consequences would most likely look like armed federal marshals ransacking their warehouses and seizing all of their products. (2)

FDA sends letters to Young Living and doTerra claiming their products are being marketed as unapproved drugs

It is not the first time that the FDA has gone after companies that sell holistic products.  The FDA has issued warning letters to producers of walnuts, cranberries, elderberry juice, and coconut oil.  Both of these essential oil companies are network-based marketing companies, which provides a unique challenge for the companies as well as the FDA.  The FDA reports that the independent distributors are “paid consultants,” therefore, the parent companies have control over how their products are being marketed by the consultants. (2)

Companies view consultants as non-employees, while FDA believes companies have complete control of “paid consultants”

The companies are viewing the situation a bit differently, stating that they have guidelines and restrictions on how their products can be marketed.  Both companies claim that their guidelines comply with FDA requirements, and that they have no control over how non-employees distribute the products.(2)

These warnings do not appear to be slowing down doTERRA.  Enthusiasts continue to state how these products help with everything from muscle pain to weight loss.  Some advocates are stating that these oils save them from antibiotics and doctor visits.(3)

Social media is serving as a platform for enthusiasts to share their experiences, making statements about their lack of doctor and pharmacy visits.(3)

Google searches for “essential oils” have tripled in the last two years, and searches for doTERRA’s name have quadrupled.  Last year’s convention had 18,000 people in attendance, and this year, the company is expecting 27,000 people to attend.  The company has not released finance information, but does report that their earnings have been doubling each year. (3)

Google searches for “essential oils” have tripled in the last two years!

Time will tell how the FDA warning letters are dealt with by these companies.  What lengths is the FDA willing to go to in order to shut down these companies, halt essential oils, or put fear into the public and distributors?

 

from:    http://www.realfarmacy.com/fda-essential-oil/

On Food Irradiation

Food Irradiation: Why It is Harmful to Your Health and Energy

food irradiation-1Pao L. Chang, Guest
Waking Times

Food irradiation, also known as “cold pasteurization” or “irradiation pasteurization,” is a food sterilization technology that has been around for nearly a century. Food irradiation is done by exposing food to ionizing radiation, which according to the EPA, “kills bacteria and other pathogens, that could otherwise result in spoilage or food poisoning.”

How is Food Irradiated?

According to the EPA, the process of irradiating food involves exposing the food to radioactive materials by passing it through a radiation beam, and therefore the food does not come in direct contact with radioactive materials.

As described at EPA.gov.

Bulk or packaged food passes through a radiation chamber on a conveyor belt. The food does not come into contact with radioactive materials, but instead passes through a radiation beam, like a large flashlight.

The type of food and the specific purpose of the irradiation determine the amount of radiation, or dose, necessary to process a particular product. The speed of the belt helps control the radiation dose delivered to the food by controlling the exposure time. The actual dose is measured by dosimeters within the food containers.

Cobalt-60 is the most commonly used radionuclide for food irradiation. However, there are also large cesium-137 irradiators and the Army has also used spent fuel rods for irradiation.

Does irradiated food sound like something you would want to eat? Even though the food does not come in direct contact with radioactive materials, it does not mean that the food is not contaminated with harmful levels of radiation.

Pros and Cons and Health Effects of Food Irradiation

The good things about using ionizing radiation to sterilize food are that it may increase the shelf life of the food, and can destroy most harmful microorganisms and insects. The bad things are that it can change the natural structures of the food and destroy many of its nutrients, making it unhealthy and even harmful to eat. As a result, your health will suffer which often leads to a lack of energy and even chronic fatigue.

As mentioned at PreventDisease.com.

Irradiated foods are exposed to high level radiation for the purpose of sterilizing it. There is an abundance of convincing evidence in the refereed scientific literature that the condensation products of the free radicals formed during irradiation produce statistically significant increases in carcinogenesis, mutagenesis and cardiovascular disease in animals and man. This is in addition to the destruction of vitamins, minerals and other nutrients.

Food irradiation is not as effective as they claim, because it does not guarantee that all microorganisms and insects are eliminated from the food. Many supporters of food irradiation claim that it is needed to prevent world hunger. This is nothing more than a big fat lie.

One of the main reasons why there is a lack of food in certain parts of the world is because of corporate farming. Corporate farming’s bad agricultural practices have destroyed many farmland due to their heavy use of toxic agrochemicals. Companies that support corporate farming do not really care about the environment. What they care about is profit.

Why You Should Not Always Rely on the FDA for Food Safety

Many people think that because the FDA has approved the use of food irradiation, food that has been irradiated should be safe enough to eat. This is not always true. The FDA is highly influenced by food companies and their lobbyists. They are the reason why the FDA is still in business.

I suggest avoiding irradiated food as much as possible because ionizing radiation can negatively affect the natural chemical structures of the food and its nutrients. If the radiation is strong enough to kill bacteria and insects, it is strong enough to cause permanent damage to the organic structures of the food.

How to Avoid Irradiated Food

  • Do not purchase food products with the Radura symbol on it.
  • If the food product has the content “treated with radiation” or “treated by irradiation,” do not buy or consume it.
  • Look for misleading labels, such as “electronically pasteurized,” “cold pasteurization,” and “irradiation pasteurization” on food products. Food products that have these labels are often treated with radiation, so avoid eating them.
  • Buy organic food at stores that specialize in whole food.
  • Buy fruits and vegetables at your local farmer’s market.

According to NaturalNews.com, the FDA’s regulations on food irradiation are not very strict. “For example, if you buy coleslaw, and the cabbage in the coleslaw has been irradiated, there is no requirement that the coleslaw carry any labeling indicating it has been irradiated.” This means that most American consumers are already eating irradiated food without even knowing it.

Sources:

About the Author

Pao L. Chang is the author and founder of EnergyFanatics.com and OmniThought.org, two comprehensive blogs dedicated to exploring topics about energy, health, conscious living, spiritual science, and exotic “free energy” technology. He loves to explore the mystery of alternative medicine, the science of consciousness, quantum mechanics, sacred geometry, and how energy affects the physical, emotional, mental, and spiritual body.

Coming Soon: GMO Apples & Potatoes

FDA Approves New GMO Foods Apples and Potatoes

FDA-Genetically-Modified-Apples-and-Potatoess9th April 2015

By Dr. Edward F. Group

Guest Writer for Wake Up World

Genetically-modified food is one of the most controversial subjects today. Not only are regulations loose and manufacturers getting away with not labeling them, they’re being approved at an alarmingly swift rate without the appropriate long-term health assessment. The Food and Drug Administration recently approved of two GMO foods, potatoes and apples, as safe and equally nutritious as conventional varieties, and they’re pushing to get these items to a grocery store near you.

The Approval of GMO Foods Apples and Potatoes

The new approval is covering six varieties of potatoes and two varieties of apples. [1] The potatoes come from Idaho from the J. R. Simplot Co., and the apples come from Canadian company Okanagan Specialty Fruits, Inc. Fortunately for the health food movement, McDonald’s, a long-time client of J. R. Simplot Co., is no longer purchasing from the company, opting out of using GMO potatoes for its food.

ConAgra is another big-name company that supplies potatoes for restaurants all across the world, and it is also in line with consumer demand for non-GMO potato varieties. While french fries and hash browns are certainly not health fare, it does go to show how companies listen and respond to the desires of consumers. In order to keep up the fight against GMOs and keep them out of our food supply, we need to continue advocating for labeling laws that will help us, as consumers, differentiate between natural food and Frankenfood.

What You Can Do

Along with contacting the FDA and urging them to look into labeling laws, there are a few things you can do to get the ball moving. Buying organic as much as possible shows companies that consumers are demanding more natural, non-GMO foods. Consumer research into buying trends weigh heavily on the actions of companies in producing their products, so vote with your pocketbook by buying as many of your products as natural as possible.

-Dr. Edward F. Group III, DC, NP, DACBN, DCBCN, DABFM

from:    http://wakeup-world.com/2015/04/09/fda-approves-new-gmo-foods-apples-and-potatoes/