Clinical Trials Day Quotes

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.

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.

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.

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.

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.

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.

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

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

Extracts of butterbur, a perennial shrub, have been used for various medicinal purposes for centuries. It has also recently gained popularity as a migraine prophylactic, and clinical trials have revealed that this is for good reason. In one randomized study (Lipton et al. 2004) butterbur (at 75 mg twice a day) reduced migraine frequency by 48 percent, compared with a 26 percent reduction for placebo.

What about the claim, by the PACE trial, that Graded Exercise Therapy and CBT can treat ME? This is a trial where you could enter moderately ill, get worse in the trial, and be declared ‘recovered’ at the end. Even the recent follow-up study conceded that, long-term, Graded Exercise and CBT are no better for ME than doing nothing. Investigative journalists and academics alike have dismissed the PACE trial as ‘clinical trial amateurism’. Like MS or epilepsy, which were also once wrongly believed to be psychiatric disorders, ME is a neurological disease, and the World Health Organisation lists it as such. I am too weak to walk more than a few metres, needing to lie in bed 21 hours a day. With the little energy I have, I am an ME patient activist.

James Young Simpson studied medicine in Edinburgh, Scotland, graduating in 1832. By the mid-1840s, Simpson had climbed the ranks to become a professor of midwifery in Edinburgh, relieving the pain of childbirth with ether, like his American colleagues. But Simpson wasn’t satisfied. He wanted a more potent agent, one that was pleasant to inhale, worked quicker, and didn’t cause vomiting upon awakening. He settled on chloroform, a combination of hydrogen, carbon, and chlorine. On November 4, 1847, Simpson invited two of his assistants, James Duncan and George Keith, and some of his friends, including a Ms. Petrie, to a dinner party. When the dinner was over, he asked his guests to sniff a variety of volatile gases, including chloroform. Duncan and Keith immediately lost consciousness, falling under the table. Ms. Petrie also lost consciousness, but not before declaring, “I’m an angel! I’m an angel! Oh, I’m an angel!” The next day, without animal studies, clinical trials, or federal approval, Simpson administered chloroform to a woman during a particularly painful delivery. “I placed her under the influence of chloroform,” recalled Simpson, “by moistening half a teaspoon of the liquid onto a pocket handkerchief [and placing it] over her mouth and nostrils. The child was expelled in about twenty minutes. When she awoke, [the mother] observed to me that she had enjoyed a very comfortable sleep.” The parents were so elated that they named their daughter Anesthesia. On November 10, 1847, Simpson told a group of colleagues what he had done. Ten days later, he described his experience in a medical journal, claiming that chloroform was more potent and easier to administer than nitrous oxide, and quicker to induce unconsciousness and less flammable than ether. Now the entire medical world knew about it.

In possibly the only clinical trial of its kind, seventeen South African adults were instructed to follow diets consisting primarily of fruit for a minimum of twelve weeks, with small amounts of nuts to satisfy nutritional requirements. The participants consumed on average twenty servings a day or more, likely containing at least 200 grams fructose. At the end of the study, the investigators observed virtually no adverse effects. To the contrary, body weight and other heart disease risk factors tended to improve despite this massive dose of fructose.57

In 2002, a Cochrane Collaboration review of the evidence concluded that low-fat diets induced no more weight loss than calorie-restricted diets, and in both cases the weight loss achieved “was so small as to be clinically insignificant.” A similar analysis was published in 2001 by the U.S. Department of Agriculture. In this case, the authors identified twenty-eight relevant trials of low-fat diets, of which at least twenty were also calorie-restricted. The overweight subjects consumed, on average, less than seventeen hundred calories a day for an average weight loss of not quite nine pounds over six months.

According to a meta-analysis of clinical trials evaluating fructose intake, 25 to 40 grams of fructose per day has no negative impact on our health.12 That’s 3 to 6 bananas, 6 to 10 cups of strawberries, 10 to 15 cherries, or 2 to 3 apples per day. Or, as the old advice goes, a few servings of fruit every day. Problems with fructose intake are only seen among those who regularly eat large amounts of refined sugars, like HFCS or sucrose. For instance, a 20-ounce bottle of soda sweetened with HFCS contains about 35 grams of fructose. One gram of sucrose is about half glucose, half fructose, so if you eat a dessert with 50 grams of sugar, you’re getting about 25 grams of fructose. Even agave nectar, which is touted as healthy by many due to its low-glycemic properties, can be as high as 90 percent fructose. Other less processed forms can be as

Putting this all together, Moore and Reiber predicted that the germ would prod people to seek out the company of others early in the infection, before it had blown its cover and triggered a counterattack by defense cells. Once they’d formulated a hypothesis, they decided it would be wise to conduct a pilot trial to see if the idea had any merit. The researchers tracked the social interactions of thirty-six people—none of whom knew the purpose of the study—before and after they got flu shots at a health clinic on the Binghamton campus. The change in the subjects’ behavior was huge, so notable that its magnitude surprised even Reiber and Moore. In the first three days after vaccination, coinciding with the time when the virus was most contagious, subjects interacted with twice as many people as they had before being inoculated. “People who had very limited or simple social lives were suddenly deciding that they needed to go out to bars or parties or invite a bunch of people over,” reported Reiber. “This happened with lots of our subjects. It wasn’t just one or two oddities.

On January 11, 2020, Chinese authorities released the virus’s genetic sequence.[11] Moderna scientists got to work with powerful machine-learning tools that analyzed what vaccine would work best against it, and just two days later they had created the sequence for its mRNA vaccine.[12] On February 7 the first clinical batch was produced. After preliminary testing, it was sent to the National Institutes of Health on February 24. And on March 16—just sixty-three days after sequence selection—the first dose went into a trial participant’s arm.

Only later would Teicher discover that Tollefson had also omitted from his talk that day information that would have been even more damaging to Lilly’s defense of Prozac: One of the company’s international clinical trials had indeed shown an increased risk of suicidal acts among patients taking Prozac (as compared to placebo). After seeing this data in 1984, the German regulatory authorities had declined to approve the drug’s use. (When Prozac was finally approved in Germany six years later, it came with a clear warning that it could cause problems and that it might be necessary for physicians to coadminister a sedative to prevent the agitation and suicidal behaviors sometimes caused by the SSRI.)

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.

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.

In a clinical trial involving 100 people, Longo’s team tested the effects of doing his fasting-mimicking diet for five days a month over three months.

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.

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.

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

In the case of bloodletting, the first comparative experiment was published in 1836 by the French doctor Pierre Louis, who had treated some pneumonia sufferers by immediately relieving them of a few pints of blood and others by holding off on the leeches for a few days. In the first group, 44% died; in the second, 25%.8 In essence, Dr. Louis had carried out the first-ever clinical trials, and bloodletting came out looking pretty dicey.

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.

Can Strawberries Reverse the Development of Esophageal Cancer? Esophageal cancer joins pancreatic cancer as one of the gravest diagnoses imaginable. The five-year survival rate is less than 20 percent,124 with most people dying within the first year after diagnosis.125 This underscores the need to prevent, stop, or reverse the disease process as early as possible. Researchers decided to put berries to the test. In a randomized clinical trial of powdered strawberries in patients with precancerous lesions in their esophagus, subjects ate one to two ounces of freeze-dried strawberries every day for six months—that’s the daily equivalent of about a pound of fresh strawberries.126 All of the study participants started out with either mild or moderate precancerous disease, but, amazingly, the progression of the disease was reversed in about 80 percent of the patients in the high-dose strawberry group. Most of these precancerous lesions either regressed from moderate to mild or disappeared entirely. Half of those on the high-dose strawberry treatment walked away disease-free.127

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