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?

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.

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 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

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

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.

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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A number of clinical trials have shown benefits (though sometimes modest) of dietary supplementation with omega-3 fatty acids in several inflammatory and autoimmune diseases, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis, lupus erythematosus, multiple sclerosis, and migraine headaches. In fact, in patients with rheumatoid arthritis, supplementation with fish oil led to substantial improvements in joint swelling, pain, and morning stiffness and enabled them to reduce their use of nonsteroidal anti-inflammatory drugs. Supplementation is beneficial because it helps correct the balance of omega-6 to omega-3 fatty acid intake. The Paleo Approach goes one very important step further because it focuses not only on increasing omega-3 fatty acids (from whole-food sources such as fish, shellfish, and pasture-raised meats) but also on decreasing omega-6 fatty acids (by avoiding processed vegetable oils, grains, legumes, nuts, and seeds). Achieving the proper ratio of omega-6 to omega-3 fatty acids will contribute substantially to the management of autoimmune disease and to overall health.

You do see different responses. Some folks might search the Web and all of their contacts, and go from center to center to see which clinical trials might be available—looking for the best possible treatment. Others withdraw in the face of this diagnosis into a depression. A lot depends on their underlying personality, their inner strengths and resources, and social support from their family and friends.

Mithoefer completed an FDA- and DEA-approved trial of MDMA for the treatment of severe PTSD, with stunning results. In 2011, with the support of MAPS, he and his team created a double-blind design in which twelve severely traumatized patients were given MDMA and psychotherapy, and eight patients were given an active placebo and psychotherapy. The researchers used the Clinician Administered PTSD Scale (CAPS) as a means of measuring symptom reduction after intervention. In the placebo group, only two out of the eight subjects had a significantly lowered CAPS score post-intervention, whereas in the MDMA group, ten out of the twelve subjects had significantly lowered CAPS scores and were able to maintain those scores at a two-month follow-up. Furthermore, in the MDMA group, ten of the twelve patients were so improved that they no longer met the DSM criteria for PTSD. The second phase of the study allowed seven subjects who had previously taken the placebo (six of whom had failed to respond to the placebo and one of whom had relapsed after the placebo) to now try MDMA. They found a clinical response rate of 100 percent, and the three people who had previously said they weren’t able to perform their jobs on account of their PTSD were now able to work once again.

Eventually, a double-blind, randomized, controlled clinical trial was performed comparing the efficacy of ginger for the treatment of migraine headaches to sumatriptan (Imitrex), one of the top-selling, billion-dollar drugs in the world. Just one-eighth of a teaspoon of powdered ginger worked just as well and just as fast as the drug (and costs less than a penny). Most migraine sufferers started with moderate or severe pain, but after taking the drug or the ginger, ended up in mild pain or were entirely pain-free.

Doctors quickly discovered that access to institutionalized populations could springboard them to lucrative contracts with drug companies and great wealth. The financial incentives became so enticing that some physicians gave up their private practices to conduct large-scale clinical trials full time. 10

In 2010 and 2015, the FDA released a pair of draft “guidance” documents on “Adaptive Design” clinical trials for drugs and medical devices, which suggests—despite a long history of sticking to an option they trust—that they might at last be willing to explore alternatives.

Given the NIH's lack of record keeping, it was impossible to say exactly how underrepresented women were, but the public learned that women had been left out of many of the largest, most important clinic studies conducted in the last couple of decades. The Baltimore Longitudinal Study of Aging, which began in 1958 and purported to explore 'normal human aging,' didn't enroll any women for the first twenty years it ran. The Physicians' Health Study, which had recently concluded that taking a daily aspirin may reduce the risk of heart disease? Conducted in 22,071 men and zero women. The 1982 Multiple Risk Factor Intervention Trial - known, aptly enough, as MRFIT - which looked at whether dietary change and exercise could help prevent heart disease: just 13,000 men.

critical part of the research process is deciding what types of data are needed to answer the research question. Administrative/claims data, secondary use of clinical trial data, prospective epidemiologic studies, and electronic

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.

In the two hundred years since the first use of clinical trials, medicine has progressed from the ideas of Galen to the wonders of gene therapy. Medicine has a long way to go, and suffers from many defects, as we shall see, but a willingness to test ideas and to learn from mistakes has transformed its performance. The irony is that while medicine has evolved rapidly, via an “open loop,” health care (i.e., the institutional question of how treatments are delivered by real people working in complex systems) has not. (The terms “closed loop” and “open loop” have particular meanings in engineering and formal systems theory, which are different from the way in which they are used in this book. So, just to reemphasize, for our purposes a closed loop is where failure doesn’t lead to progress because information on errors and weaknesses is misinterpreted or ignored; an open loop does lead to progress because the feedback is rationally acted upon.)

Why is this? How can experience be so valuable in some professions but almost worthless in others? To see why, suppose that you are playing golf. You are out on the driving range, hitting balls toward a target. You are concentrating, and every time you fire the ball wide you adjust your technique in order to get it closer to where you want it to go. This is how practice happens in sport. It is a process of trial and error. But now suppose that instead of practicing in daylight, you practice at night—in the pitch-black. In these circumstances, you could practice for ten years or ten thousand years without improving at all. How could you progress if you don’t have a clue where the ball has landed? With each shot, it could have gone long, short, left, or right. Every shot has been swallowed by the night. You wouldn’t have any data to improve your accuracy. This metaphor solves the apparent mystery of expertise. Think about being a chess player. When you make a poor move, you are instantly punished by your opponent. Think of being a clinical nurse. When you make a mistaken diagnosis, you are rapidly alerted by the condition of the patient (and by later testing). The intuitions of nurses and chess players are constantly checked and challenged by their errors. They are forced to adapt, to improve, to restructure their judgments. This is a hallmark of what is called deliberate practice. For psychotherapists things are radically different. Their job is to improve the mental functioning of their patients. But how can they tell when their interventions are going wrong or, for that matter, right? Where is the feedback? Most psychotherapists gauge how their clients are responding to treatment not with objective data, but by observing them in clinic. But these data are highly unreliable. After all, patients might be inclined to exaggerate how well they are to please the therapist, a well-known issue in psychotherapy. But there is a deeper problem. Psychotherapists rarely track their clients after therapy has finished. This means that they do not get any feedback on the lasting impact of their interventions. They have no idea if their methods are working or failing—if the client’s long-term mental functioning is actually improving. And that is why the clinical judgments of many practitioners don’t improve over time. They are effectively playing golf in the dark.11

Lind’s 1747 experiment looked at scurvy. Twelve sailors who had the illness were divided into six groups. The accommodations and diet of all the sailors were identical, but each received a different remedy: one group received cider; one got seawater; another, “elixir of vitriol”; the fifth group, two oranges and a lemon; and the sixth, a mix of spices with barley water. It was the first documented clinical trial in medical history.

Saffron The earliest recorded medical use of a spice appears to be more than 3,600 years ago, when saffron was evidently first used for healing.43 A few thousand years later, scientists finally put saffron to the test in a head-to-head trial against the antidepressant drug Prozac for the treatment of clinical depression. Both the spice and the drug worked equally well in reducing depression symptoms.44 As you can see in the box here, this may not be saying much, but at the very least, the saffron was safer in terms of side effects. For example, 20 percent of people in the Prozac group suffered sexual dysfunction, a common occurrence with many antidepressant medications, whereas no one in the saffron group did. However, saffron may be one of those rare cases in which the natural remedy is more expensive than the drug. Saffron is the world’s most expensive spice. It is harvested from crocus flowers, specifically the dried stigmas

uterine fibroids (benign tumors of the uterus) have been treated, thus avoiding hysterectomies and infertility. Clinical trials for tumors of the brain, breast, pancreas and liver, as well as Parkinson’s disease, arthritis,

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.

The Medical Research Council’s PACE Trial of behavioural interventions for Chronic Fatigue Syndrome / Myalgic Encephalomyelitis (CFS/ME) attracted considerable opposition from the outset and the Principal Investigators had difficulty in recruiting a sufficient number of participants. PACE is the acronym for Pacing, Activity, and Cognitive behavioural therapy, a randomised Evaluation, interventions that, according to one of the Principal Investigators, are without theoretical foundation. The MRC’s PACE Trial seemingly inhabits a unique and unenviable position in the history of medicine. It is believed to be the first and only clinical trial that patients and the charities that support them have tried to stop before a single patient could be recruited and is the only clinical trial that the Department for Work and Pensions (DWP) has ever funded.

This is not science fiction. Around the world, 50,000 men with prostate cancer have been treated with focused ultrasound. Over 36,000 women with uterine fibroids (benign tumors of the uterus) have been treated, thus avoiding hysterectomies and infertility. Clinical trials for tumors of the brain, breast, pancreas, and liver, as well as Parkinson’s disease and arthritis, are inching forward at over 270 research sites around the world.

Meanwhile, our patchwork regulatory system insures that no single institution is keeping track of how many deaths and injuries befall healthy subjects in clinical trials. Nobody appears to be tracking how many clinical investigators are incompetent of have lost their licenses, or have questionable disciplinary records.. Nobody is monitoring the effect that so many trials have on the health of professional guinea pigs. In fact, nobody is even certain whether the trials generate reliable data.

A few thousand years later, scientists finally put saffron to the test in a head-to-head trial against the antidepressant drug Prozac for the treatment of clinical depression. Both the spice and the drug worked equally well in reducing depression symptoms.44 As you can see in the box here, this may not be saying much, but at the very least, the saffron was safer in terms of side effects. For example, 20 percent of people in the Prozac group suffered sexual dysfunction, a common occurrence with many antidepressant medications, whereas no one in the saffron group did. However, saffron may be one of those rare cases in which the natural remedy is more expensive than the drug. Saffron is the world’s most expensive spice. It is harvested from crocus flowers, specifically the dried stigmas (the threadlike tips inside the flower), which are ground up to make the spice. You need more than fifty thousand crocuses—enough to cover a football field—to produce just a single pound of saffron.45 A Prozac-equivalent dose of saffron may cost more than twice as much as the drug, but a subsequent study found that even just smelling saffron appeared to have psychological benefits. Though researchers diluted the spice so much that the study subjects couldn’t detect its odor, they still noted a significant drop in stress hormones measured in women who sniffed the saffron for twenty minutes compared with those who spent twenty minutes smelling a placebo, along with significant improvement in the women’s symptoms of anxiety.

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.

Gates’s strong patronage of HPV vaccines (Gardasil and Cervarix) deepened suspicions that he was weaponizing vaccination against human fertility. Merck’s clinical trials showed strong signals for reproductive harm from Gardasil.177, 178 People in the study suffered reproductive problems including premature ovarian failure at ten times background rates. Female fertility has dropped precipitously beginning in 2006 in the United States, coterminous with Gardasil uptake.179, 180 Historical drops in fecundity have occurred in every nation with high Gardasil uptake.181

In the midst of a pandemic, with hundreds of thousands of deaths attributed to COVID, and the economy in free fall, Dr. Fauci’s suggestion that we withhold promising treatments that have an established safety profile—from patients who have a potentially lethal disease—pending the completion of randomized controlled clinical trials, is highly manipulative and utterly unethical. It is not medically ethical to allow a COVID-19 patient to deteriorate in the early stages of the infection when there is an inexpensive, safe, and demonstrably effective HCQ treatment that CDC’s and NIAID’s own studies show blocks coronavirus replication. It would be equally unethical to enroll sick individuals in such studies—as Dr. Fauci proposes—in which half the infected patients would receive a placebo.

What was the new research he was referencing? A research document that claimed to show benefit to masking based on reviewing a collection of studies, which somehow ignored all of the randomized controlled trials showing no effect from masking. These kinds of glaring omissions have been a continuous problem among scientists desperate to justify the implementation of masks despite the gold standard of evidence indicating they would be effectively useless. One randomized controlled trial did occur during 2020, conducted by researchers in Denmark. Those researchers’ objective was clearly stated: “To assess whether recommending surgical mask use outside the home reduces wearers’ risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures.”25 Given all of the pre-COVID scientific research, it should come as no surprise that the results showed no benefit to mask wearing to protect against infection with COVID-19. The Denmark researchers’ summary clearly identifies the lack of any significant impact: “The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers.” Thousands of Danes were enrolled in this trial, the most comprehensive effort by any scientific researchers to study the potential effect of mask wearing by the general public. Participants were provided high-quality surgical masks, not the cloth face coverings recommended by many public health agencies. In the best approximation of a gold-standard clinical trial that researchers could design, the results showed absolutely no statistically significant benefit. The findings, surprisingly, received no major media attention, nor did they generate questions for the expert community that now universally embrace masking.

In 2019, Dr. A. Luciano et al. reported a list of drugs repurposed for colorectal cancer treatment currently in clinical trials. This list includes: aspirin, celecoxib, doxycycline, etodolac, indomethacin, mebendazole, metformin, niclosamide, propranolol, simvastatin, and valproate. (35)

For example, if I were to propose a clinical trial involving children and entice participation by giving out ice cream to those willing to participate, any Institutional Human Subject’s Safety Board (IRB) in the United States would reject that protocol. If I were to propose a clinical research protocol wherein the population of a geographic region would lose personal liberties unless 70% of the population participated in my study, once again, that protocol would be rejected by any US IRB based on coercion of subject participation. No coercion to participate in the study is allowed. In the case of human subject clinical research, in most countries of the world this is considered a bright line that cannot be crossed. So, now we are told to waive that requirement without even so much as open public discussion being allowed?

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.

The room made her feel like an experiment had gone wrong where error had overtaken trial which didn’t even bother anymore because there was no room for an additional hypothesis, plus or minus one clinical test.

Since the time of the ancient Greeks, doctors have known that women respond differently to medicine than men. However, women have historically been, and often continue to be, excluded from clinical trials. Why is that? Menstruation.

Butterbur (Petasites hybridus) has been used for decades to treat allergies as well as asthma and migraine headaches and is one of the few botanicals to go head-to-head with a drug in a clinical trial.

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.

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

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.

Had ketamine been a new drug, pharmaceutical companies would have had a strong incentive to fund the kind of robust clinical trials federal regulators would have required to approve its use as a treatment for depression. But ketamine’s patent expired in 2002, which meant there was little to gain by bankrolling years of costly research.

In the last decade or so, however, a new generation of brain imaging studies and clinical trials has put meditation firmly on the scientific map. They’re showing that although watching our thoughts might seem ephemeral, it can have hard physical effects on our brains and bodies.

observation is simply an observation for which a specified outcome has not yet occurred. Assume that data exist from a random sample of 100 clients who are seeking, or have found, employment. Survival analysis is the statistical procedure for analyzing these data. The name of this procedure stems from its use in medical research. In clinical trials, researchers want to know the survival (or disease) rate of patients as a function of the duration of their treatment. For patients in the middle of their trial, the specified outcome may not have occurred yet. We obtain the following results (also called a life table) from analyzing hypothetical data from welfare records (see Table 18.3). In the context shown in the table, the word terminal signifies that the event has occurred. That is, the client has found employment. At start time zero, 100 cases enter the interval. During the first period, there are no terminal cases and nine censored cases. Thus, 91 cases enter the next period. In this second period, 2 clients find employment and 14 do not, resulting in 75 cases that enter the following period. The column labeled “Cumulative proportion surviving until end of interval” is an estimate of probability of surviving (not finding employment) until the end of the stated interval.5 The column labeled “Probability density” is an estimate of the probability of the terminal event occurring (that is, finding employment) during the time interval. The results also report that “the median survival time is 5.19.” That is, half of the clients find employment in 5.19 weeks. Table 18.2 Censored Observations Note: Obs = observations (clients); Emp = employment; 0 = has not yet found employment; 1 = has found employment. Table 18.3 Life Table Results

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

Because faeces are not drugs, and all you need is a kitchen blender, some saline and a sieve, with a little help from YouTube videos, anyone can administer their own faecal transplant, and many thousands do. Among those giving it a go, not surprisingly, are the parents of autistic children. Dr Borody himself has seen improvements in autistic children following both faecal transplants and after repeatedly delivering faecal microbes via a flavoured drink. His intention was to relieve the gastrointestinal symptoms, not the psychiatric ones, but Borody says several of the children improved following their treatment. The most encouraging was a young child with a vocabulary of just over twenty words, which shot up to around 800 in the weeks after the microbial therapy. For now, all this is anecdotal. As yet not a single clinical trial has been carried out to test the effects of faecal transplant on autistic patients, though some are planned. The lack of evidence won’t stop the parents though – for many, anything is worth a try.

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.

Six years after her Parkinson’s disease diagnosis, Kimberly suffered from involuntary shaking and could no longer ride her bike or enjoy other forms of exercise. She was successfully treated in a focused ultrasound clinical trial at the University of Maryland. She is now back on her bike and says the clock has been turned back on her life.

In the industry, the typical product development cycle is about one year and consists of a number of product clinics followed by larger product trials culminating in the decision for a full-scale launch.