Clinical Trial Quotes

It had been tested extensively in clinical trials in third-world countries;

Ethical AI systems aim to end the practice of using people from low-income backgrounds as test subjects in clinical trials and also support their equal rights in patent claims and revenue generation from the medicines.

Because drugs have become so profitable, major medical journals rarely publish studies on nondrug treatments of mental health problems.31 Practitioners who explore treatments are typically marginalized as “alternative.” Studies of nondrug treatments are rarely funded unless they involve so-called manualized protocols, where patients and therapists go through narrowly prescribed sequences that allow little fine-tuning to individual patients’ needs. Mainstream medicine is firmly committed to a better life through chemistry, and the fact that we can actually change our own physiology and inner equilibrium by means other than drugs is rarely considered.

some years later, that he had “faith,” then add, “I also have faith in penicillin, rifampin, isoniazid, and the good absorption of the fluoroquinolones, in bench science, clinical trials, scientific progress, that HIV is the cause of every case of AIDS, that the rich oppress the poor, that wealth is flowing in the wrong direction, that this will cause more epidemics and kill millions. I have faith that those things are true, too. So if I had to choose between lib theo, or any ology, I would go with science as long as service to the poor went along with it. But I don’t have to make that choice, do I?

In 1999 the RAND Corporation published a report (the first and, so far, last of its kind) with a “conservative estimate” that more than 307 million tissue samples from more than 178 million people were stored in the United States alone. This number, the report said, was increasing by more than 20 million samples each year. The samples come from routine medical procedures, tests, operations, clinical trials, and research donations. They sit in lab freezers, on shelves, or in industrial vats of liquid nitrogen. They’re stored at military facilities, the FBI, and the National Institutes of Health.

The lack of social support and sympathy is an additional trial: disabled, but with the nature of her disability not clear—she is not, after all, manifestly blind or paralysed, manifestly anything—she tends to be treated as a phoney or a fool.

the NIH held a series of workshops in the 1980s to address the fact that the early clinical trials using diets high in soybean oil showed subjects dying of cancer at alarmingly elevated rates. Gallstones were also associated with diets high in vegetable oils.

It was a bad day for viruses,” Moderna’s chair Afeyan says about the Sunday in November 2020 when he got the first word of the clinical trial results. “There was a sudden shift in the evolutionary balance between what human technology can do and what viruses can do. We may never have a pandemic again.

Antidepressant drugs that increase serotonin in the brain have the same modest effect, in clinical trials, as drugs that reduce serotonin in the brain.

When an active placebo is used, most clinical trials do not show a significant benefit for antidepressants.

Blood pressure readings are an inexact technique, like ECG interpretation, X-ray interpretation, pain scores, and many other measurements that are routinely used in clinical trials. I

Wilson-Donovan wanted to move ahead as quickly as possible to clinical trials on patients, which was why it was so important to test Vicotec’s safety now before the FDA hearings in September, which would hopefully put it on the “Fast Track.” Peter was absolutely sure that the testing being concluded by Paul-Louis Suchard, the head of the laboratory in Paris, would only confirm the good news he had just been given in Geneva.

Despite decades of obesity research, and billions of dollars spent in the laboratory and on clinical trials, the bedrock fundamental concept underlying all nutrition and dietary advice is that fat and lean people are effectively identical physiologically, and that our bodies respond to what we eat the same way, except that the fat people at some point in their lives ate too much and expended too little energy and so became fat, while the lean people didn’t.

advancements are memorialized in the names of the structures they accurately described—Gabriele Fallopio (fallopian tubes; also invented the first condom and studied it in a clinical trial!) and Caspar Bartholin (Bartholin’s glands).

In March 1987, Gilbert White, a hematologist, conducted the first clinical trial of the hamster-cell-derived recombinant factor VIII at the Center for Thrombosis in North Carolina. The first patient to be treated was G.M., a forty-three-year-old man with hemophilia. As the initial drops of intravenous liquid dripped into his veins, White hovered anxiously around G.M.’s bed, trying to anticipate reactions to the drug. A few minutes into the transfusion, G.M. stopped speaking. His eyes were closed; his chin rested on his chest. “Talk to me,” White urged. There was no response. White was about to issue a medical alert when G.M. turned around, made the sound of a hamster, and burst into laughter.

If, in recommending that Americans avoid meat, cheese, milk, cream, butter, eggs, and the rest, it turns out that nutrition experts made a mistake, it will have been a monumental one. Measured just by death and disease, and not including the millions of lives derailed by excess weight and obesity, it’s very possible that the course of nutrition advice over the past sixty years has taken an unparalleled toll on human history. It now appears that since 1961, the entire American population has, indeed, been subjected to a mass experiment, and the results have clearly been a failure. Every reliable indicator of good health is worsened by a low-fat diet. Whereas diets high in fat have been shown, again and again, in a large body of clinical trials, to lead to improved measures for heart disease, blood pressure, and diabetes, and are better for weight loss. Moreover, it’s clear that the original case against saturated fats was based on faulty evidence and has, over the last decade, fallen apart. Despite more than two billion dollars in public money spent trying to prove that lowering saturated fat will prevent heart attacks, the diet-heart hypothesis has not held up.

And in the case of fecal transplants, there’s no drug or medical device involved, and thus no pharmaceutical company or device maker with diverticula deep enough to fund the multiple rounds of controlled clinical trials. If anything, drug companies might be inclined to fight the procedure’s approval. Pharmaceutical companies make money by treating diseases, not by curing them. “There’s billions of dollars at stake,” says Khoruts. “I told Katerina, if this works, don’t be surprised to find me at the bottom of the river.

I think this is going to trigger ‘Sputnik 2.0,’ a biomedical duel on progress between China and the United States,” said Carl June, a noted cancer researcher at the University of Pennsylvania who at the time was still struggling to get regulatory approval for a similar clinical trial.

phase three clinical trial found that rhodiola exerts an antifatigue effect that increases mental performance and concentration and decreases cortisol response in burnout patients with fatigue syndrome; other studies have found similar outcomes including the amelioration of depression and anxiety.

Clinical trials have proven that projectile vomiting is up to FOUR times more efficient than ordinary vomiting. You don't even have to run to the bathroom! With practice, and careful placement of your chair within thirty feet--and line of sight--of your bathroom, you can project your lunch from the comfort of your armchair.

According to an article in the Washington Post: The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found that drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday. Regulators supressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies' plans to reveal the negative studies in drug labels.

The pharmaceutical companies were going to use Theranos’s blood-testing system to monitor patients’ response to new drugs. The cartridges and readers would be placed in patients’ homes during clinical trials. Patients would prick their fingers several times a day and the readers would beam their blood-test results to the trial’s sponsor.

Kevin floated a trial idea. To him the protesters at the front gate were the equivalent of the protesters outside abortion clinics. The Rock Hudsons tried to stop people coming here the same way do-gooders tried to block people going to murder their unborn kids. The irony was in how those same rescued babies got adopted by Rock Hudsons. Kevin

In 2004, the FDA urged drug companies to adopt a 'Don't ask, don't tell' policy with respect to their clinical-trial data showing that antidepressants are not better than placebos for depressed children. If the data were made public, they cautioned, it might lead doctors to not prescribe antidepressants. The FDA believed that the jury was still out on antidepressants for children. Even if the clinical trials show negative results, an FDA spokesperson was reported to have said to a Washington Post reporter, it doesn't mean that the drugs are ineffective. The assumption seems to have been that doctors should prescribe medications that have not been shown to work, until it has been proven that they don't work.

Over time, the grueling job of a mother requires one to learn everything from patience to clinical psychology. When you are "in the fire," it is sometimes hard to recognize the value of what you are learning. But the da-to-day refining process--the problem solving, crisis resolution, mental stretching, mess clean-ups, sleep deprivation, and loving more than you thought possible truly makes you into a smart, aware, beautiful refined individual. The great secret is appreciating the refined person you are becoming through your trials.

It should come as absolutely no surprise that research has ignored women for so long because the establishment: the journal publishers, the reviewers and the funding agencies has rewarded it. Although the things are changing for the better in the US federal agencies will no longer fund clinical trials involving humans that do not include women... there is still a long way to go [..] Thoughtful, carefully done research on females still takes longer and costs more and is often times harder to interpret than research conducted only on males. So when people's careers depend on their publication rate rather than the need for answers to the questions they are asking, women and the issues they care about most - loose.

It’s important to realize that in 1970, when the AHA started telling Americans to cut back on total fat, this regime had not been tested in clinical trials. All those famous big, early trials had been on the “low-cholesterol,” or “prudent” diet—high in vegetable oils and low in saturated fats—but when it came to reducing fat overall, as the AHA was now advising, the evidence was nonexistent.

The good news is that these detox symptoms typically begin tapering within a couple of weeks for our clinical trial participants. In my clinical practice, I tell people to wind down the bad food as they wind up the good food over a week. When it is done that way, the detox symptoms are generally somewhat less bothersome. And remember what’s happening when you feel them: The bad stuff is coming out!

The default to studying men at times veered into absurdity: in the early sixties, observing that women tended to have lower rates of heart disease until their estrogen levels dropped after menopause, researchers conducted the first trial to look at whether supplementation with the hormone was an effective preventive treatment. The study enrolled 8,341 men and no women. (Although doctors began prescribing estrogens to postmenopausal women in droves - by the midseventies, a third would be taking them - it wasn't until 1991 that the first clinical study of hormone therapy was conducted in women.) An NIH-supported pilot study from Rockefeller University looked at how obesity affected breast and uterine cancer didn't enroll a single woman. While men can develop breast cancer - and a small number of them do each year - as Rep. Snowe noted drily at the congressional hearings, 'Somehow I find it hard to believe that the male-dominated medical community would tolerate a study of prostate cancer that used only women as research subjects.

1) The overall success rate for drugs moving from early stage Phase I clinical trials to FDA approval is about one in 10 (10%). —Reuters 2) The average drug can take anywhere from 8 - 18 years from pre-clinical (development) to clinical (phase 1, 2, and 3) to FDA approval. 3) The average cost to bring a drug to market: Phase 1 $15.2 million; Phase 2 $23.4 million; Phase 3 $86.5 million (total = $125.1 million) —FDA.gov

Many of the benefits of CBT (cognitive behavioral therapy) can be obtained without going into therapy. There are a number of self-help books, CDs and computer programs that have been used to treat depression and some of these have been tested in clinical trials with positive results. I can particularly recommend these two books. One is 'Control Your Depression', the lead author of which is Peter Lewinsohn, a Professor of Psychology at the University of Oregon. ... The other book that I can recommend with confidence is 'Feeling Good' by the psychiatrist David Burns. 'Control Your Depression' emphasizes behavioral techniques like increasing pleasant activities, improving social skills and learning to relax. 'Feeling Good' puts greater emphasis on changing the way people think about themselves. But both books include both cognitive and behavioral techniques.

Antidepressants fail to outperform placebos in up to half of clinical trials. Armed with fMRI technology, brain scientists now understand that assuming we are born with chemical imbalances is putting the chicken before the egg—trauma changes the structure and chemical and hormonal responses of our brains. In many cases, we can’t just pump opposing chemicals into our brains with the assumption that things will change. We have to treat the underlying, original cause: the trauma.

A special type of fiber called beta-glucan in brewer’s, baker’s, and nutritional yeasts displays anti-inflammatory effects3956 sufficient to improve wound healing3957 and alleviate symptoms in ragweed sufferers.3958 Randomized, double-blind, placebo-controlled clinical trials of about two teaspoons of nutritional yeast’s worth of beta-glucans have resulted in about an inch off the waist within six weeks3959 or up to a five-pound weight benefit compared to controls in twelve weeks, along with an improvement in blood pressure.3960

I’d walked to school like it was any other day. Like my heart wasn’t breaking. Like my head wasn’t reeling and my feet weren’t weighted down by the sudden and tragic onset of clinical depression, making each breath a trial, each step a struggle. I totally needed a car.

Elder Maxwell on Wintry Doctrines Elder Maxwell said that “if we are serious about our discipleship Jesus will eventually request each of us to do those very things which are most difficult for us to do.” This was what he came to call the wintry doctrine at the funeral of a young father in 1996 he put it this way “There are in the gospel warm and cuddly doctrines and then there are some that are just outright wintry doctrines… one of them frankly is that we cannot approach real consecration without passing through appropriate clinical experiences because we don’t achieve consecration in the abstract. … sometimes therefore the best people have the worst experiences… because they are the most ready to learn.” (Bruce C. Hafen, The Story of A Disciple’s Life: Preparing the Biography of Neal A. Maxwell, p. 14)

It has been found to possess antibiotic, antiviral, anti-inflammatory, anticarcinogenic, expectorant, antifungal, immune-stimulating, antiallergenic, laxative, antianemic, and tonic properties. Because honey increases calcium absorption in the body, it is also recommended for women in menopause to help prevent osteoporosis. In clinical trials, honey has been found to be especially effective in treating stomach ulceration (especially if caused by Helicobacter pylori bacteria), infected wounds, severe skin ulceration, and respiratory illnesses.

I believe that it is the task of social science to produce nuanced and people-centered forms of knowledge, correcting asymmetries of information and helping to promote, to the best of our ability, informed consent, human protection, and safety in medical and research settings.

A systematic review and meta-analysis published in the Journal of the American Medical Association looked at all the best randomized clinical trials evaluating the effects of omega-3 fats on life span, cardiac death, sudden death, heart attack, and stroke. These included studies not only on fish oil supplements but also studies on the effects of advising people to eat more oily fish. What did they find? Overall, the researchers found no protective benefit for overall mortality, heart disease mortality, sudden cardiac death, heart attack, or stroke.12

Federal law requires that every injury or death following vaccination during clinical trials—or, by logical extension, with emergency use products—must be attributed to the vaccine unless proven otherwise. Nevertheless, as of August 2021, the CDC officially took the Pollyannaish view that not one of the 13,000-plus deaths162 reported to VAERS following vaccination as of August 20, 2021, was vaccine related.163 Not one. As was the case with Hank Aaron, CDC apparently did nothing to actively investigate any of those deaths, exonerating the vaccines, instead, by fiat.

She’s afraid she might never enjoy her freedom without a taint of guilt. Her clinically unstable first husband had tried to throw himself out of a window and to take her with him, yet, even after this, she can’t entirely accept having left him: “I chose me. My guilt about this haunts me still.

So do red and processed meats actually cause cancer or not? We don’t know, and we will probably never get a more definitive answer, because a clinical trial testing this proposition is unlikely ever to be done. Confusion reigns. Nevertheless, I’m going to stick my neck out and assert that a risk ratio of 1.17 is so minimal that it might not matter that much whether you eat red/processed meats versus some other protein source, like chicken. Clearly, this particular study is very far from providing a definitive answer to the question of whether red meat is “safe” to eat. Yet people have been fighting about it for years.

S-adenosyl-methionine (SAMe) is a natural derivative of an amino acid normally produced by the body, and it plays a role in methylation (see Chapter 5). Levels of SAMe in the body often become depleted by middle age. Multiple clinical trials have shown that SAMe provides substantial benefit for patients with depression. This effect occurs relatively quickly, unlike the requirement to build up levels in the bloodstream that accompanies some prescription drugs for depression. It is, therefore, an effective, natural, and quick-acting treatment for mild depression. Human trials have also shown benefits for strengthening the liver and for relief from osteoarthritis.

CDC cited Merck’s and Gates’s cheery assessments of the grotesque Indian experiments to help justify its expanded recommendation for the Gardasil vaccine. Prior to COVID-19, Gardasil was the most dangerous vaccine ever licensed, accounting for some 22 percent of cumulative injuries from all adverse events reported to the US Vaccine Adverse Events Reporting System (VAERS). During clinical trials, Merck was unable to show that Gardasil was effective against cervical cancers.173 Instead, the studies showed the vaccine actually increases cervical cancer by 46.3 percent in women exposed to HPV prior to vaccination—perhaps one-third of all women.174 According to Merck’s clinical trial reports, the

A 2020 clinical trial by Ethan Weiss and colleagues found no weight loss or cardiometabolic benefits in a group of 116 volunteers on a 16/8 eating pattern. Two similar studies also found minimal benefit. One other study did find that shifting the eating window to early in the day, from 8 a.m. to 2 p.m., actually did result in lower twenty-four-hour glucose levels, reduced glucose excursions, and lower insulin levels compared to controls. So perhaps an early-day feeding window could be effective, but in my view sixteen hours without food simply isn’t long enough to activate autophagy or inhibit chronic mTOR elevation, or engage any of the other longer-term benefits of fasting that we would want to obtain. Another

Experiments, especially the Oslo trials of 1981-84 and the Lipid Research Clinics trials, the results of which were announced in 1984, did show that a low-fat diet could lower high cholesterol levels and reduce the risk of heart disease—but most people do not have a high cholesterol level, regardless of their diet, and more than 50 percent of those with afflicted hearts do not have high cholesterol counts.

The antibacterial and anti-inflammatory properties of honey were revealed as a result of clinical observations and research. Honey is exceedingly effective in painlessly cleaning up infection and dead cells in these regions and in the development of new tissues. The use of honey as a medicine is mentioned in the most ancient writings. In the present day, doctors and scientists are rediscovering the effectiveness of honey in the treatment of wounds. Dr. Peter Molan, a leading researcher into honey for the last 20 years and a professor of biochemistry at New Zealand's University of Waikato, says this about the antimicrobial properties of honey: "Randomized trials have shown that honey is more effective in controlling infection in burn wounds than silver sulphadiazine, the antibacterial ointment most widely used on burns in hospitals.

In March, while people were dying at the rate of 10,000 patients a week, Dr. Fauci declared that hydroxychloroquine should only be used as part of a clinical trial.104 For the first time in American history, a government official was overruling the medical judgment of thousands of treating physicians, and ordering doctors to stop practicing medicine as they saw fit. Boldly and relentlessly, Dr. Fauci kept declaring that “The Overwhelming Evidence of Properly Conducted Randomized Clinical Trials Indicate No Therapeutic Efficacy of Hydroxychloroquine (HCQ).”105 Dr. Fauci failed to disclose that NONE of the trials he had used as the basis for that pronouncement involved medication given in the first five to seven days after onset of symptoms. Instead, all of those randomized controlled trials targeted patients who were already sick enough to be hospitalized.

What are the health effects of the choice between austerity and stimulus? Today there is a vast natural experiment being conducted on the body economic. It is similar to the policy experiments that occurred in the Great Depression, the post-communist crisis in eastern Europe, and the East Asian Financial Crisis. As in those prior trials, health statistics from the Great Recession reveal the deadly price of austerity—a price that can be calculated not just in the ticks to economic growth rates, but in the number of years of life lost and avoidable deaths. Had the austerity experiments been governed by the same rigorous standards as clinical trials, they would have been discontinued long ago by a board of medical ethics. The side effects of the austerity treatment have been severe and often deadly. The benefits of the treatment have failed to materialize. Instead of austerity, we should enact evidence-based policies to protect health during hard times. Social protection saves lives. If administered correctly, these programs don’t bust the budget, but—as we have shown throughout this book—they boost economic growth and improve public health. Austerity’s advocates have ignored evidence of the health and economic consequences of their recommendations. They ignore it even though—as with the International Monetary Fund—the evidence often comes from their own data. Austerity’s proponents, such as British Prime Minister David Cameron, continue to write prescriptions of austerity for the body economic, in spite of evidence that it has failed. Ultimately austerity has failed because it is unsupported by sound logic or data. It is an economic ideology. It stems from the belief that small government and free markets are always better than state intervention. It is a socially constructed myth—a convenient belief among politicians taken advantage of by those who have a vested interest in shrinking the role of the state, in privatizing social welfare systems for personal gain. It does great harm—punishing the most vulnerable, rather than those who caused this recession.

In 2003, a Dutch clinical psychologist named Christof van Nimwegen began a fascinating study of computer-aided learning that a BBC writer would later call “one of the most interesting examinations of current computer use and the potential downsides of our increasing reliance on screen-based interaction with information systems.”26 Van Nimwegen had two groups of volunteers work through a tricky logic puzzle on a computer. The puzzle involved transferring colored balls between two boxes in accordance with a set of rules governing which balls could be moved at which time. One of the groups used software that had been designed to be as helpful as possible. It offered on-screen assistance during the course of solving the puzzle, providing visual cues, for instance, to highlight permitted moves. The other group used a bare-bones program, which provided no hints or other guidance. In the early stages of solving the puzzle, the group using the helpful software made correct moves more quickly than the other group, as would be expected. But as the test proceeded, the proficiency of the members of the group using the bare-bones software increased more rapidly. In the end, those using the unhelpful program were able to solve the puzzle more quickly and with fewer wrong moves. They also reached fewer impasses—states in which no further moves were possible—than did the people using the helpful software. The findings indicated, as van Nimwegen reported, that those using the unhelpful software were better able to plan ahead and plot strategy, while those using the helpful software tended to rely on simple trial and error. Often, in fact, those with the helpful software were found “to aimlessly click around” as they tried to crack the puzzle.

It would be a mistake to imagine that drug companies are the only people applying pressure for fast approvals. Patients can also feel they are being deprived of access to drugs, especially if they are desperate. In fact, in the 1980s and 1990s the key public drive for faster approvals came from an alliance forged between drug companies and AIDS activists such as ACT UP. At the time, HIV and AIDS had suddenly appeared out of nowhere, and young, previously healthy gay men were falling ill and dying in terrifying numbers, with no treatment available. We don’t care, they explained, if the drugs that are currently being researched for effectiveness might kill us: we want them, because we’re dying anyway. Losing a couple of months of life because a currently unapproved drug turned out to be dangerous was nothing, compared to a shot at a normal lifespan. In an extreme form, the HIV-positive community was exemplifying the very best motivations that drive people to participate in clinical trials: they were prepared to take a risk, in the hope of finding better treatments for themselves or others like them in the future. To achieve this goal they blocked traffic on Wall Street, marched on the FDA headquarters in Rockville, Maryland, and campaigned tirelessly for faster approvals.

the slow, contemplative “academic” mechanism of drug testing, Kramer groused, was becoming life-threatening rather than lifesaving. Randomized, placebo-controlled trials were all well and good in the cool ivory towers of medicine, but patients afflicted by a deadly illness needed drugs now. “Drugs into bodies; drugs into bodies,” ACT UP chanted. A new model for accelerated clinical trials was needed. “The FDA is fuckedup, the NIH is fucked-up… the boys and girls who are running this show have been unable to get whatever system they’re operating to work,” Kramer told his audience in New York. “Double-blind studies,” he argued in an editorial, “were not created with terminal illnesses in mind.” He concluded, “AIDS sufferers who have nothing to lose, are more than willing to be guinea pigs.” Even Kramer knew that that statement was extraordinary; Halsted’s ghost had, after all, barely been laid to rest. But as ACT UP members paraded through the streets of New York and Washington, frothing with anger and burning paper effigies of FDA administrators, their argument ricocheted potently through the media and the public imagination. And the argument had a natural spillover to other, equally politicized diseases. If AIDS patients demanded direct access to drugs and treatments, should other patients with terminal illnesses not also make similar demands? Patients with AIDS wanted drugs into bodies, so why should bodies with cancer be left without drugs?

Kid, I won’t lie to you. We’d have dumped your body in the river, or we could have all gone to jail.” If that had happened, I’d have been adopted or remained with the nuns forever. Shocking as Dave’s answer now sounds, prosecutions of those who carried out abortions were commonplace. Police kicking down the doors of clinics and private homes was as everyday as their raids on brothels and gambling dens. Those who were caught helping women faced prison sentences (once again, not unlike now) of an average of three to five years and lost their license to practice if they had medical qualifications. The women were generally regarded as victims and coerced into testifying, but the stigma of the trial could ruin them, so the risks were enormous for everyone.

In March, at HHS’s request, several large pharmaceutical companies—Novartis, Bayer, Sanofi, and others—donated their inventory, a total of 63 million doses of hydroxychloroquine and 2 million of chloroquine, to the Strategic National Stockpile, managed by BARDA, an agency under the DHHS Assistant Secretary for Preparedness and Response.56 BARDA’s Director, Dr. Rick Bright, later claimed the chloroquine drugs were deadly, and he needed to protect the American public from them.57 Bright colluded with FDA to restrict use of the donated pills to hospitalized patients. FDA publicized the authorization using language that led most physicians to believe that prescribing the drug for any purpose was off-limits. But at the beginning of June, based on clinical trials that intentionally gave unreasonably high doses to hospitalized patients and failed to start the drug until too late, FDA took the unprecedented step of revoking HCQ’s emergency authorization,58 rendering that enormous stockpile of valuable pills off limits to Americans while conveniently indemnifying the pharmaceutical companies for their inventory losses by allowing them a tax break for the donations. After widespread use of the drug for 65 years, without warning, FDA somehow felt the need to send out an alert on June 15, 2020 that HCQ is dangerous, and that it required a level of monitoring only available at hospitals.59 In a bit of twisted logic, Federal officials continued to encourage doctors to use the suddenly-dangerous drug without restriction for lupus, rheumatoid arthritis, Lyme and malaria. Just not for COVID. With the encouragement of Dr. Fauci and other HHS officials, many states simultaneously imposed restrictions on HCQ’s use.

The issues of antidepressant-associated suicide has become front-page news, the result of an analysis suggesting a link between medication use and suicidal ideation among children, adolescents, a link between medication use and suicidal ideation among children, adolescents, and adults up to age 24 in short term (4 to 16 weeks), placebo-controlled trials of nine newer antidepressant drugs. The data from trials involving more than 4.4(K) patients suggested that the average risk of suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants was 4 percent, twice the placebo risk of 2 percent. No suicides occured in these trials. The analysis also showed no increase in suicide risk among the 25 to 65 age group. Antidepressants reduced suicidality among those over age 65. Following public hearings on the subject, in October 2004, the FDA requested the addition of “black box” warnings—the most serious warning placed on the labeling of a prescription medication—to all antidepressant drugs, old and new.

Every Day Take Your Daily Doses Black Cumin (Nigella sativa) (¼ tsp) As noted in the Appetite Suppression section, a systematic review and meta-analysis of randomized, controlled weight-loss trials found that about a quarter teaspoon of black cumin powder every day appears to reduce body mass index within a span of a couple of months. Note that black cumin is different from regular cumin, for which the dosing is different. (See below.) Garlic Powder (¼ tsp) Randomized, double-blind, placebo-controlled studies have found that as little as a daily quarter teaspoon of garlic powder can reduce body fat at a cost of perhaps two cents a day. Ground Ginger (1 tsp) or Cayenne Pepper (½ tsp) Randomized controlled trials have found that ¼ teaspoon to 1½ teaspoons a day of ground ginger significantly decreased body weight for just pennies a day. It can be as easy as stirring the ground spice into a cup of hot water. Note: Ginger may work better in the morning than evening. Chai tea is a tasty way to combine the green tea and ginger tweaks into a single beverage. Alternately, for BAT activation, you can add one raw jalapeño pepper or a half teaspoon of red pepper powder (or, presumably, crushed red pepper flakes) into your daily diet. To help beat the heat, you can very thinly slice or finely chop the jalapeño to reduce its bite to little prickles, or mix the red pepper into soup or the whole-food vegetable smoothie I featured in one of my cooking videos on NutritionFacts.org.4985 Nutritional Yeast (2 tsp) Two teaspoons of baker’s, brewer’s, or nutritional yeast contains roughly the amount of beta 1,3/1,6 glucans found in randomized, double-blind, placebo-controlled clinical trials to facilitate weight loss. Cumin (Cuminum cyminum) (½ tsp with lunch and dinner) Overweight women randomized to add a half teaspoon of cumin to their lunches and dinners beat out the control group by four more pounds and an extra inch off their waists. There is also evidence to support the use of the spice saffron, but a pinch a day would cost a dollar, whereas a teaspoon of cumin costs less than ten cents. Green Tea (3 cups) Drink three cups a day between meals (waiting at least an hour after a meal so as to not interfere with iron absorption). During meals, drink water, black coffee, or hibiscus tea mixed 6:1 with lemon verbena, but never exceed three cups of fluid an hour (important given my water preloading advice). Take advantage of the reinforcing effect of caffeine by drinking your green tea along with something healthy you wish you liked more, but don’t consume large amounts of caffeine within six hours of bedtime. Taking your tea without sweetener is best, but if you typically sweeten your tea with honey or sugar, try yacon syrup instead. Stay

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In April, Dr. Vladimir (Zev) Zelenko, M.D., an upstate New York physician and early HCQ adopter, reproduced Dr. Didier Raoult’s “startling successes” by dramatically reducing expected mortalities among 800 patients Zelenko treated with the HCQ cocktail.29 By late April of 2020, US doctors were widely prescribing HCQ to patients and family members, reporting outstanding results, and taking it themselves prophylactically. In May 2020, Dr. Harvey Risch, M.D., Ph.D. published the most comprehensive study, to date, on HCQ’s efficacy against COVID. Risch is Yale University’s super-eminent Professor of Epidemiology, an illustrious world authority on the analysis of aggregate clinical data. Dr. Risch concluded that evidence is unequivocal for early and safe use of the HCQ cocktail. Dr. Risch published his work—a meta-analysis reviewing five outpatient studies—in affiliation with the Johns Hopkins Bloomberg School of Public Health in the American Journal of Epidemiology, under the urgent title, “Early Outpatient Treatment of Symptomatic, High-Risk COVID-19 Patients that Should be Ramped-Up Immediately as Key to Pandemic Crisis.”30 He further demonstrated, with specificity, how HCQ’s critics—largely funded by Bill Gates and Dr. Tony Fauci31—had misinterpreted, misstated, and misreported negative results by employing faulty protocols, most of which showed HCQ efficacy administered without zinc and Zithromax which were known to be helpful. But their main trick for ensuring the protocols failed was to wait until late in the disease process before administering HCQ—when it is known to be ineffective. Dr. Risch noted that evidence against HCQ used late in the course of the disease is irrelevant. While acknowledging that Dr. Didier Raoult’s powerful French studies favoring HCQ efficacy were not randomized, Risch argued that the results were, nevertheless, so stunning as to far outweigh that deficit: “The first study of HCQ + AZ [ . . . ] showed a 50-fold benefit of HCQ + AZ vs. standard of care . . . This is such an enormous difference that it cannot be ignored despite lack of randomization.”32 Risch has pointed out that the supposed need for randomized placebo-controlled trials is a shibboleth. In 2014 the Cochrane Collaboration proved in a landmark meta-analysis of 10,000 studies, that observational studies of the kind produced by Didier Raoult are equal

On the one hand, I recognize the power of the placebo effect: if you believe it’s working, it may well work. If you think an object brings you luck, you are more confident. And yet what the Italian students in the “lucky” seats showed wasn’t confidence; it was overconfidence. They thought they were doing better, but the evidence didn’t actually back them up. And then there’s the flip side of the placebo, the nocebo effect: the belief in evil signs or bad luck. It turns out people can literally scare themselves to death. If you think you’ve been cursed or otherwise made ill, you may end up actually getting sick, failing to improve poor health, or, yes, dying altogether. In one medically documented instance, a man was given three months to live after a diagnosis of metastatic cancer of the esophagus. He died shortly after. When his body was autopsied, doctors realized that he had been misdiagnosed: he did indeed have cancer, but a tiny, non-metastatic tumor on his liver. Clinically speaking, it could not have killed him. But, it seems, being told he was dying of a fatal illness brought about that very outcome. In another case, a man thought he was hexed by a voodoo priest. He came close to death, only to recover miraculously after an enterprising doctor “reversed” the curse through a series of made-up words. In yet a third, a man almost died in the emergency room after overdosing on pills. He’d been in a drug trial for depression and decided to end his life with the antidepressants he’d been prescribed. His vitals were so bad when he was admitted that doctors didn’t think he would make it—until they discovered his blood was completely clear of any drugs. He’d been taking a placebo. Once he found out he had not in fact taken a life-threatening quantity of pills, he recovered quickly. The effect our mind has on our body makes for a scary proposition. Belief is a powerful thing. Our mental state is crucial to our performance. And ultimately, while some superstitions may give you a veneer of false confidence, they also have the power to destroy your mental equilibrium. I like to think of this as the black cat effect. You see one cross the parking lot as you walk to a tournament. You brood about the bad luck. Your game is thrown off. You blame the cat. You bust. You feel validated. Superstitions are false attributions, so they give you a false sense of your own abilities and in the end, impede learning.

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Take the case of Jackson Silva, who as a newborn in 2014, started showing signs of pain and was diagnosed with a form of spinal muscular atrophy. When his parents were informed that nothing could be done, they found a clinical trial in Ohio. “Jackson was the third child in the world to receive treatment. And while 90% of children with SMA pass away before the age of two, and 50% pass away before 6 months old, Jackson is still here because of the investigational drug he is receiving. Jackson’s parents want all children with SMA to have access to this drug, not just the lucky few who have been accepted into a clinical trial.”5 For those interested, please visit RightToTry.Org.

Salmon calcitonin (SCT) has been an available therapeutic agent for over 30 years. The analgesic properties of SCT have been documented in several prospective clinical trials. Studies that

[C]lients seen in public mental health centers and general clinical practices are often more complex and potentially more challenging to work with than those who are screened and selected to participate in randomized clinical trials (RCTs; Briere & Lanktree, 2011; Lanktree et al., 2013; Spinazzola, Blaustein, & van der Kolk, 2005; Westen, Novontny, & Thompson-Brenner, 2004) and may be less responsive to RCT-developed treatment methodologies (Zayfert et al., 2005).

And then there’s the flip side of the placebo, the nocebo effect: the belief in evil signs or bad luck. It turns out people can literally scare themselves to death. If you think you’ve been cursed or otherwise made ill, you may end up actually getting sick, failing to improve poor health, or, yes, dying altogether. In one medically documented instance, a man was given three months to live after a diagnosis of metastatic cancer of the esophagus. He died shortly after. When his body was autopsied, doctors realized that he had been misdiagnosed: he did indeed have cancer, but a tiny, non-metastatic tumor on his liver. Clinically speaking, it could not have killed him. But, it seems, being told he was dying of a fatal illness brought about that very outcome. In another case, a man thought he was hexed by a voodoo priest. He came close to death, only to recover miraculously after an enterprising doctor “reversed” the curse through a series of made‑up words. In yet a third, a man almost died in the emergency room after overdosing on pills. He’d been in a drug trial for depression and decided to end his life with the antidepressants he’d been prescribed. His vitals were so bad when he was admitted that doctors didn’t think he would make it—until they discovered his blood was completely clear of any drugs. He’d been taking a placebo. Once he found out he had not in fact taken a life-threatening quantity of pills, he recovered quickly. The effect our mind has on our body makes for a scary proposition.

This demand was further supported by industry fundamentals: 80 percent of emerging biotech companies were developing treatments in rare disease or oncology, our areas of focus. If only a portion of these came to Seeker Health for clinical trial enrollment, we would be just fine.

But like every other human defect, we have used science to outsmart our own biology. We can take a brain that is shredded ear to ear and we can put it back together with mantras like this one. Mantras that have been tested in clinical trials. Vetted in peer articles and TED Talks and now appear in self-help books. You just put one foot in front of the other, Molly. Every day, just one more step.

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Subject: Your interview in last month’s Science magazine Hi Dr. Johnson, I’m just completing my biology degree at Case Western Reserve University, and I found your thoughts on the Cleveland Clinic’s trial use of nanomachines to address certain forms of cancer in last month’s issue of Science to be very interesting. Would you mind discussing your work further with me in a brief phone chat? I had a few follow-up questions, and your insights would be invaluable. Thank you for your time, Caroline Thomas

That 2006 ACIP panel recommended two new blockbuster Merck shots: the Gardasil HPV vaccine for all girls ages nine through twenty-six,76 and three doses of a Merck rotavirus vaccine, Rotateq, for infants at ages two, four, and six months.77 Both Bill Gates78 and Tony Fauci (via NIAID)79 had provided seed and clinical trial funding for the development of both Gardasil and the rotavirus vaccine.80,81 Merck maintained it had not tested either vaccine against an inert placebo in pre-approval trials, so no one could scientifically predict if the vaccines would avert more injuries or cancers than they would cause.

Mom knew everyone’s name. She’d whisper it to me before they got to the bottom of the steps. Foreign princes and dignitaries, real estate moguls and politicians, actors. There was even a famous vlogger here, a big donor for the ALS clinical trials Royaume was doing.

For example, if you want to combat high blood pressure, start by using a combination of lavender, ylang ylang and frankincense. Diffuse cinnamon oil, grapefruit oil and ginger oil at your desk at work to support blood sugar balance. In clinical trials, essential oils have been proven to elevate moods,

Vaccinating Children is Unethical Our collective nausea can only amplify when we ask, “Why are we vaccinating children?” Kirsch’s model estimates that 600 children have already died from COVID vaccines as of September 2021. A recent Lancet study shows that a healthy child has zero risk for COVID, suggesting that most of these kids are dying unnecessarily.99 Some 86 percent of children suffered an adverse reaction to the Pfizer COVID vaccine in clinical trial. And one in nine children suffered a serious reaction grave enough to leave them unable to perform daily activities. How can we then justify forcing a healthy child to take a vaccine that is dead certain to injure many and kill some while bestowing no benefits? “How can anyone consider it ethical,” asks Kirsch, “to put a child at risk, for the pretext that it might shield an adult? Show me any adult who thinks this is okay, and I’ll show you a monster!

Even the results of clinical trials, which are usually randomized experiments and therefore the gold standard of medical research, should be viewed with some skepticism. In 2011, the Wall Street Journal ran a front-page story on what it described as one of the “dirty little secrets” of medical research: “Most results, including those that appear in top-flight peer-reviewed journals, can’t be reproduced.”7

One reason for this “dirty little secret” is the positive publication bias described in Chapter 7. If researchers and medical journals pay attention to positive findings and ignore negative findings, then they may well publish the one study that finds a drug effective and ignore the nineteen in which it has no effect. Some clinical trials may also have small samples (such as for a rare diseases), which magnifies the chances that random variation in the data will get more attention than it deserves. On top of that, researchers may have some conscious or unconscious bias, either because of a strongly held prior belief or because a positive finding would be better for their career.

One reason for this “dirty little secret” is the positive publication bias described in Chapter 7. If researchers and medical journals pay attention to positive findings and ignore negative findings, then they may well publish the one study that finds a drug effective and ignore the nineteen in which it has no effect. Some clinical trials may also have small samples (such as for a rare diseases), which magnifies the chances that random variation in the data will get more attention than it deserves. On top of that, researchers may have some conscious or unconscious bias, either because of a strongly held prior belief or because a positive finding would be better for their career. (No one ever gets rich or famous by proving what doesn’t cure cancer.)

was exploring something called Decoded Neurofeedback. It resembled old-fashioned biofeedback, but with neural imaging for real-time, AI-mediated feedback. A first group of subjects—the “targets”—entered emotional states in response to external prompts, while researchers scanned relevant regions of their brains using fMRI. The researchers then scanned the same brain regions of a second group of subjects—the “trainees”—in real time. AI monitored the neural activity and sent auditory and visual cues to steer the trainees toward the targets’ prerecorded neural states. In this way, the trainees learned to approximate the patterns of excitation in the targets’ brains, and, remarkably, began to report having similar emotions. The technique dated back to 2011, and it claimed some impressive early results. Teams in Boston and Japan taught trainees to solve visual puzzles faster, simply by training them on the visual cortex patterns of targets who’d learned the puzzles by trial and error. Other experimenters recorded the visual fields of target subjects exposed to the color red. Trainees who learned, through feedback, to approximate that same neural activity reported seeing red in their mind’s eye. Since those days, the field had shifted from visual learning to emotional conditioning. The big grant money was going to desensitizing people with PTSD. DecNef and Connectivity Feedback were being touted as treatments to all kinds of psychiatric disorders. Marty Currier worked on clinical applications. But he was also pursuing

recent paper describes a clinical trial where a platinum-based chemotherapy was used in combination with a checkpoint inhibitor, resulting in improved overall survival in patients with lung cancer.

There are many examples of how Medicine 2.0 gets risk wrong, but one of the most egregious has to do with hormone replacement therapy (HRT) for postmenopausal women, long entrenched as standard practice before the results of the Women’s Health Initiative Study (WHI) were published in 2002. This large clinical trial, involving thousands of older women, compared a multitude of health outcomes in women taking HRT versus those who did not take it. The study reported a 24 percent relative increase in the risk of breast cancer among a subset of women taking HRT, and headlines all over the world condemned HRT as a dangerous, cancer-causing therapy. All of a sudden, on the basis of this one study, hormone replacement treatment became virtually taboo. This reported 24 percent risk increase sounded scary indeed. But nobody seemed to care that the absolute risk increase of breast cancer for women in the study remained minuscule. Roughly five out of every one thousand women in the HRT group developed breast cancer, versus four out of every one thousand in the control group, who received no hormones. The absolute risk increase was just 0.1 percentage point. HRT was linked to, potentially, one additional case of breast cancer in every thousand patients. Yet this tiny increase in absolute risk was deemed to outweigh any benefits, meaning menopausal women would potentially be subject to hot flashes and night sweats, as well as loss of bone density and muscle mass, and other unpleasant symptoms

of menopause—not to mention a potentially increased risk of Alzheimer’s disease, as we’ll see in chapter 9. Medicine 2.0 would rather throw out this therapy entirely, on the basis of one clinical trial, than try to understand and address the nuances involved. Medicine 3.0 would take this study into account, while recognizing its inevitable limitations and built-in biases. The key question that Medicine 3.0 asks is whether this intervention, hormone replacement therapy, with its relatively small increase in average risk in a large group of women older than sixty-five, might still be net beneficial for our individual patient, with her own unique mix of symptoms and risk factors. How is she similar to or different from the population in the study? One huge difference: none of the women selected for the study were actually symptomatic, and most were many years out of menopause. So how applicable are the findings of this study to women who are in or just entering menopause (and are presumably younger)? Finally, is there some other possible explanation for the slight observed increase in risk with this specific HRT protocol?[*3] My broader point is that at the level of the individual patient, we should be willing to ask deeper questions of risk versus reward versus cost for this therapy—and for almost anything else we might do. The fourth and perhaps largest shift is that where Medicine 2.0 focuses largely on lifespan, and is almost entirely geared toward staving off death, Medicine 3.0 pays far more attention to maintaining healthspan, the quality of life. Healthspan was a concept that barely even existed when I went to medical school. My professors said little to nothing about how to help our patients maintain their physical and cognitive capacity as they aged. The word exercise was almost never uttered. Sleep was totally ignored, both in class and in residency, as we routinely worked twenty-four hours at a stretch. Our instruction in nutrition was also minimal to nonexistent. Today, Medicine 2.0 at least acknowledges the importance of healthspan, but the standard definition—the period of life free of disease or disability—is totally insufficient, in my view. We want more out of life than simply the absence of sickness or disability. We want to be thriving, in every way, throughout the latter half of our lives. Another, related issue is that longevity itself, and healthspan in particular, doesn’t really fit into the business model of our current

Clinical trials of fenugreek with daily dose equivalents as low as a quarter teaspoon4361 to two-thirds of a teaspoon4362 were found to raise testosterone levels4363 by about 10 percent within three months, accompanied by a rise in sex drive and arousal.

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Over the next couple of years, Cole and the rest of psychiatry settled on a trial design for testing psychotropic drugs. Psychiatrists and nurses would use “rating scales” to measure numerically the characteristic symptoms of the disease that was to be studied. Did a drug for schizophrenia reduce the patient’s “anxiety”? His or her “grandiosity”? “Hostility”? “Suspiciousness”? “Unusual thought content”? “Uncooperativeness”? The severity of all of those symptoms would be measured on a numerical scale and a total “symptom” score tabulated, and a drug would be deemed effective if it reduced the total score significantly more than a placebo did within a six-week period. At least in theory, psychiatry now had a way to conduct trials of psychiatric drugs that would produce an “objective” result. Yet the adoption of this assessment put psychiatry on a very particular path: The field would now see short-term reduction of symptoms as evidence of a drug’s efficacy. Much as a physician in internal medicine would prescribe an antibiotic for a bacterial infection, a psychiatrist would prescribe a pill that knocked down a “target symptom” of a “discrete disease.” The six-week “clinical trial” would prove that this was the right thing to do. However, this tool wouldn’t provide any insight into how patients were faring over the long term. Were they able to work? Were they enjoying life? Did they have friends? Were they getting married? None of those questions would be answered. This was the moment that magic-bullet medicine shaped psychiatry’s future. The use of the clinical trial would cause psychiatrists to see their therapies through a very particular prism, and even at the 1956 conference, New York State Psychiatric Institute researcher Joseph Zubin warned that when it came to evaluating a therapy for a psychiatric disorder, a six-week study induced a kind of scientific myopia. “It would be foolhardy to claim a definite advantage for a specified therapy without a two- to five-year follow-up,” he said. “A two-year follow-up would seem to be the very minimum for the long-term effects.

It is true that vaccines have in the past taken a long, long time to develop. Until 2020, a new vaccine usually took at least ten years to develop from concept to roll-out. Many took much longer. The malaria vaccine programme at the Jenner Institute has been going for twenty-five years, and research into malaria vaccines had been going on for more than a hundred years – so far, with limited success. The lab-to-jab record-holder was the mumps vaccine, developed in four years by Maurice Hilleman in the United States in the 1960s.1 But the standard lengthy timeline we were all used to was never because vaccine development required ten, fifteen or thirty years of continuous painstaking lab work, clinical trials and data analysis. For every vaccine that had ever been developed up until 2020, most of the elapsed development time was spent waiting. In 2020, there were three key factors that enabled us to cut out the waiting and crunch ten years into one: first, the work we had already done; second, changes to the way funding was given out; and third, doing in parallel things that we would normally do in sequence.

what’s most curious in clinical trials with psilocybin is that participants who have the most mystical experiences, as defined by the Mystical Experience Questionnaire (MEQ), a peer reviewed psychological scale,52 also seem to benefit the most from psychedelic therapy, no matter if the study is for addiction53 or end-of-life anxiety.54 But why?

Indeed, we’re finding that increasing your salt intake, even above what’s generally considered a normal intake, may help improve your insulin sensitivity. One clinical trial found that compared to consumption of about 3,000 milligrams of sodium per day, those who consumed around 6,000 milligrams of sodium per day significantly lowered their glucose response to a 75-gram oral glucose tolerance test. Moreover, the researchers found that when diabetic patients were placed on the higher-sodium diet, their insulin response improved. The authors were quite emphatic and suggested that some people even supplement with sodium, stating that “an abundant sodium intake may improve glucose tolerance and insulin resistance, especially in diabetic, salt-sensitive, or medicated essential hypertensive subjects.”27

In January 2003, as Gates and Dr. Fauci opened dozens of clinical trials for experimental AIDS vaccines across Africa,

Since 1984, undeterred by thirty-seven years of broken promises, failed clinical trials, billions of squandered dollars, and uncounted human carnage, Dr. Fauci and his old crony Bob Gallo continue to ride the AIDS vaccine gravy train. Neither man has advanced the search for a cure, but both have built impressive institutions.

In the 1980s, Pharma therefore moved most of its clinical trials to poor nations where human guinea pigs are cheap and even the most severe injuries will rarely delay the study. Government complicity and anemic corporate liability laws allow vaccine makers to write off injuries as collateral damage with little consequence or accountability.

In clinical trials, desvenlafaxine was shown to reduce hot flashes by 62 percent and to lessen their severity by 25 percent. Escitalopram reduced hot flash severity by about 50 percent. On the other hand, common antidepressants such as fluoxetine (Prozac) and sertraline (Zoloft) do not work as well for menopausal symptoms as the other antidepressants listed.

In 2018, Gilead entered remdesivir in a NIAID-funded clinical trial against Ebola in Africa.9 This is how we know that Anthony Fauci was well aware of remdesivir’s toxicity when he orchestrated its approval for COVID patients

playbook that he developed during his early AIDS years, and then used repeatedly across his career to win approvals for deadly and ineffective drugs. Time and again, he has terminated clinical trials of his sweetheart drugs the moment they begin to reveal cataclysmic toxicity. He makes the absurd claim that his drug-du-jour had proven so miraculously effective that it would be unethical to deny it to the public, and then he strong-arms FDA to grant his approvals.

The government moved aggressively to block its use. On December 24, in what seemed like a trial balloon, the South African government quietly banned the importation of ivermectin. YouTube soon scrubbed Kory’s video64 and Facebook blocked him. Then in March 2021 the US FDA, the European Medicines Association (EMA), and the WHO issued statements advising against the use of ivermectin for COVID-19. The EMA said it should not be used at all. The WHO, echoing its strategy for tanking hydroxychloroquine, said ivermectin’s use should be limited to clinical trials (the high costs of running a clinical trial and their reliance on NIH, NIAID, Gates, or pharma funding means that their results may be easily controlled). FDA issued a much firmer directive: “You should not use ivermectin to treat or prevent COVID-19.”65

In 1996, doctors performed a peak of six hundred thousand heart bypass operations. In the 2000s, more than a million angioplasties were performed annually. Yet when randomized clinical trials were finally conducted, results showed that bypass surgery and angioplasty did not extend life expectancy any more than medication and lifestyle changes did except for a few of the sickest patients.

Doctors were effectively killing patients for the better part of 1,700 years not because they lacked intelligence or compassion, but because they did not recognize the flaws in their own procedures. If they had conducted a clinical trial (an idea we will return to),* they would have spotted the defects in bloodletting: and this would have set the stage for progress.

Clinical trials for vaccine approval by the FDA exclusively evaluate single-vaccine products, even though infants following the CDC schedule receive up to six vaccines at the same time.

Readers of these pages will learn how in exalting patented medicine Dr. Fauci has, throughout his long career, routinely falsified science, deceived the public and physicians, and lied about safety and efficacy. Dr. Fauci’s malefactions detailed in this volume include his crimes against the hundreds of Black and Hispanic orphan and foster children whom he subjected to cruel and deadly medical experiments and his role, with Bill Gates, in transforming hundreds of thousands of Africans into lab rats for low-cost clinical trials of dangerous experimental drugs that, once approved, remain financially out of reach for most Africans. You will learn how Dr. Fauci and Mr. Gates have turned the African continent into a dumping ground for expired, dangerous, and ineffective drugs, many of them discontinued for safety reasons in the US and Europe.

AIDS activists and public health officials were wondering, “Where did all the grant money go? Did NIAID keep the money? Who benefited? Certainly not the tens of thousands of people with AIDS who grew angrier and angrier with each wasted, passing day.”19 Activists complained that Dr. Fauci was not being forthcoming about the status and enrollment of his clinical trials. He was stonewalling inquiries and had veiled the entire process in secrecy.

This is how we know that Anthony Fauci was well aware of remdesivir’s toxicity when he orchestrated its approval for COVID patients. NIAID sponsored that project. Dr. Fauci had another NIAID-incubated drug, ZMapp, in the same clinical trial, testing efficacy against Ebola alongside two experimental monoclonal antibody drugs. Researchers planned to administer all four drugs to Ebola patients across Africa over a period of four to eight months.10,11 However, six months into the Ebola study, the trial’s Safety Review Board suddenly pulled both remdesivir and ZMapp from the trial.12 Remdesivir, it turned out, was hideously dangerous. Within 28 days, subjects taking remdesivir had lethal side effects including multiple organ failure, acute kidney failure, septic shock, and hypotension, and 54 percent of the remdesivir group died—the highest mortality rate among the four experimental drugs.13 Anthony Fauci’s drug, ZMapp, ran up the second-highest body count at 44 percent. NIAID was the primary funder of this study, and its researchers published the bad news about remdesivir in the New England Journal of Medicine in December 2019.

trial and error. Other experimenters recorded the visual fields of target subjects exposed to the color red. Trainees who learned, through feedback, to approximate that same neural activity reported seeing red in their mind’s eye. Since those days, the field had shifted from visual learning to emotional conditioning. The big grant money was going to desensitizing people with PTSD. DecNef and Connectivity Feedback were being touted as treatments to all kinds of psychiatric disorders. Marty Currier worked on clinical applications. But he was also pursuing a more exotic side-hustle. “Why not?” I told my wife. And so we volunteered in her friend’s experiment. IN THE RECEPTION AREA OF CURRIER’S LAB, Aly and I chuckled over the entrance questionnaire. We would be among the second wave of target subjects, but first we had to pass the screening. The questions disguised furtive motives. HOW OFTEN DO YOU THINK ABOUT THE PAST? WOULD YOU RATHER BE ON A CROWDED BEACH OR IN AN EMPTY MUSEUM? My wife shook her head at these crude inquiries and touched a hand to her smile. I read the expression as clearly as if we were wired up together: The investigators were welcome to anything they discovered inside her, so long as it didn’t lead to jail time. I’d given up on understanding my own hidden temperament a long time ago. Lots of monsters inhabited my sunless depths, but most of them were nonlethal. I did badly want to see my wife’s answers, but a lab tech prevented us from comparing questionnaires. DO YOU USE TOBACCO? Not for years. I didn’t mention that all my pencils were covered with bite marks. HOW MUCH ALCOHOL DO YOU DRINK A WEEK? Nothing for me, but my wife confessed to her nightly Happy Hour, while plying the dog with poetry. DO YOU SUFFER FROM ANY ALLERGIES? Not unless you counted cocktail parties. HAVE YOU EVER EXPERIENCED DEPRESSION? I didn’t know how to answer that one. DO YOU PLAY A MUSICAL INSTRUMENT? Science. I said I might be able to find middle C on a piano, if they needed it. Two postdocs took us into the fMRI room. These people had way more cash to throw around than any astrobiology team anywhere. Aly was having the same thoughts

Pfizer filed with the FDA on Friday, November 20, seeking authorization for emergency use of the vaccine.35 It was the first company to seek permission to offer a COVID vaccine to US patients. It was just 248 days since the company had first set out with BioNTech to develop the vaccine. No vaccine had ever been developed that fast. The process involved 150 different clinical trial sites, 43,661 patient volunteers, the work of thousands of Pfizer colleagues, and the hopes of a weary nation: it was one of the largest, fastest, and most important scientific endeavors of its kind in modern history.

In March, while people were dying at the rate of 10,000 patients a week, Dr. Fauci declared that hydroxychloroquine should only be used as part of a clinical trial.104 For the first time in American history, a government official was overruling the medical judgment of thousands of treating physicians, and ordering doctors to stop practicing medicine as they saw fit.