Clinical Trials Quotes

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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.
Sri Amit Ray (Ethical AI Systems: Frameworks, Principles, and Advanced Practices)
It had been tested extensively in clinical trials in third-world countries;
John Grisham (The Litigators)
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.
Bessel van der Kolk (The Body Keeps the Score: Brain, Mind, and Body in the Healing of Trauma)
Antidepressant drugs that increase serotonin in the brain have the same modest effect, in clinical trials, as drugs that reduce serotonin in the brain.
Johann Hari (Lost Connections: Uncovering the Real Causes of Depression – and the Unexpected Solutions)
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.
Oliver Sacks (The Man Who Mistook His Wife For A Hat: And Other Clinical Tales)
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.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
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.
Rebecca Skloot (The Immortal Life of Henrietta Lacks)
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.
Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race)
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?
Tracy Kidder (Mountains Beyond Mountains: The Quest of Dr. Paul Farmer, a Man Who Would Cure the World)
When an active placebo is used, most clinical trials do not show a significant benefit for antidepressants.
Irving Kirsch (The Emperor's New Drugs: Exploding the Antidepressant Myth)
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
Ben Goldacre (Bad Science)
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.
Gary Taubes (The Case for Keto: Rethinking Weight Control and the Science and Practice of Low-Carb/High-Fat Eating)
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.
Siddhartha Mukherjee (The Gene: An Intimate History)
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.
Mary Roach (Gulp: Adventures on the Alimentary Canal)
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.
Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race)
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.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
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.
Stephen Harrod Buhner (Herbal Antivirals: Natural Remedies for Emerging & Resistant Viral Infections)
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.
Chris Dolley (How Possession Can Help You Lose Weight)
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.
Irving Kirsch (The Emperor's New Drugs: Exploding the Antidepressant Myth)
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.
John Carreyrou (Bad Blood: Secrets and Lies in a Silicon Valley Startup)
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
Chuck Palahniuk (Make Something Up: Stories You Can't Unread)
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.
Linda Eyre (A Mother's Book of Secrets)
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.
Sarah E. Hill (This Is Your Brain on Birth Control: The Surprising Science of Women, Hormones, and the Law of Unintended Consequences)
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.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
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!
Terry Wahls (The Wahls Protocol : How I Beat Progressive MS Using Paleo Principles and Functional Medicine)
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.
Maya Dusenbery (Doing Harm: The Truth About How Bad Medicine and Lazy Science Leave Women Dismissed, Misdiagnosed, and Sick)
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
Penny Reid (Marriage of Inconvenience (Knitting in the City, #7))
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.
Danielle Steel (Five Days in Paris)
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.
Irving Kirsch (The Emperor's New Drugs: Exploding the Antidepressant Myth)
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.
Stephanie Foo (What My Bones Know: A Memoir of Healing from Complex 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
Michael Greger (How Not to Diet)
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.
Darynda Jones (Death and the Girl Next Door (Darklight, #1))
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)
Neal A. Maxwell
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.
Stephen Harrod Buhner (The Natural Testosterone Plan: For Sexual Health and Energy)
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.
Adriana Petryna (When Experiments Travel: Clinical Trials and the Global Search for Human Subjects)
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
Michael Greger (How Not to Die: Discover the Foods Scientifically Proven to Prevent and Reverse Disease)
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.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
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.
Mona Chollet (In Defense of Witches: The Legacy of the Witch Hunts and Why Women Are Still on Trial)
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.
Ray Kurzweil (Transcend: Nine Steps to Living Well Forever)
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
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
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.
Irving Kirsch (The Emperor's New Drugs: Exploding the Antidepressant Myth)
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.
Felipe Fernández-Armesto (Near a Thousand Tables)
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.
Harun Yahya (Allah's Miracles in the Qur'an)
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.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
By the logic used to approve BiDil, drugs tested on Americans should never be marketed overseas, or drugs tested only on whites should not be made available to anyone else. That logic had never resulted in a racial indication before. In the past, the FDA has generalized clinical trials involving white patients to approve drugs for everyone because it is assumed that white bodies function like all human bodies. By approving BiDil only for use in black patients, the FDA emphasized the supposedly distinctive—and, it is implied, substandard—quality of black bodies.30 The FDA treated white heart failure patients as the norm and blacks as a special case that had to be given a specialized therapy that Nissen compared to an orphan drug and that could not be assumed to work for other people. The message is: black people cannot represent all of humanity as well as white people can.
Dorothy Roberts (Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century)
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.
David Stuckler (The Body Economic: Why Austerity Kills)
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.
Nicholas Carr (The Shallows: What the Internet is Doing to Our Brains)
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.
Ben Goldacre (Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients)
Believing in race can be compared to believing in astrology. People who have faith in astrology find constant confirmation that horoscope predictions are reliable and that astrological signs determine personality types. For the faithful, the twelve divisions of the zodiac are as accurate as Blumenbach’s five divisions of human beings. The funny thing is, biostatisticians can find significant medical differences according to astrological signs. In the 1990s, a major randomized clinical trial compared the effectiveness of an intravenous drug, an oral aspirin, and a placebo to treat 17,000 patients who were hospitalized with signs of a heart attack. The study found a huge overall statistical benefit for patients who got the aspirin over the placebo. To test the strength of the outcome, the researchers divided the patients into twelve subgroups by their astrological signs. They found that the zodiac made a difference: their statistical analysis showed that patients born under Gemini or Libra suffered an adverse effect from aspirin.72 Unsurprisingly, physicians laughed off this finding because it was more scientifically plausible to interpret the results as an insignificant coincidence. But an astrology enthusiast would take it as proof that zodiac signs determine people’s health and drug response.
Dorothy Roberts (Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century)
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?
Siddhartha Mukherjee (The Emperor of All Maladies)
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.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
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.
Benjamin James Sadock (Kaplan & Sadock's Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry)
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
Michael Greger (How Not to Diet)
Although there are certainly a number Hair Loss regarding treatments offering great results, experts say that normal thinning hair treatment can easily yield some of the best rewards for anybody concerned with the fitness of their head of hair. Most people choose to handle their hair loss along with medications or even surgical treatment, for example Minoxidil or even head of hair hair transplant. Nevertheless many individuals fail to realize that treatment as well as surgical procedure are costly and may have several dangerous unwanted effects and also risks. The particular safest and a lot cost efficient form of thinning hair treatment therapy is natural hair loss remedy, which includes healthful going on a diet, herbal solutions, exercise as well as good hair care strategies. Natural thinning hair therapy is just about the "Lost Art" associated with locks restore and is frequently ignored as a type of treatment among the extremely expensive options. A simple main within normal hair loss treatment methods are that the identical food items which are great for your health, are good for your hair. Although hair loss may be caused by many other factors, not enough correct diet will cause thinning hair in most people. Foods which are loaded with protein, lower in carbohydrates, and have decreased excess fat articles can help in maintaining healthful hair as well as preventing hair loss. For instance, efa's, seen in spinach, walnuts, soy products, seafood, sardines, sunflower seed products and also canola acrylic, are important eating essentials valuable in maintaining hair wholesome. The omega-3 and also rr Half a dozen efas contain anti-inflammatory properties that are valuable in maintaining healthier hair. Insufficient amounts of these types of efa's may lead to more rapidly hair loss. A deficiency in nutritional B6 and also vitamin B12 can also result in excessive hair thinning. Food items containing B vitamins, like liver organ, poultry, seafood and soybean are important to healthier hair growth and normal thinning hair treatment. Both vitamin B6 and also vitamin B12 are simply within protein rich foods, which are needed to preserve natural hair growth. Vitamin b are incredibly essential to your diet plan to avoid extreme hair thinning. Certain nutritional vitamins as well as supplements are often essential to recover protein amounts which in turn, are helpful in stopping thinning hair. Growing b vitamin consumption in your diet is an effective method to avoid or perhaps treat hair damage naturally. Alongside the thought of eating healthily regarding vitamins, nutrients and also vitamins and minerals are also the utilization of herbal treatments which are good at preventing hair thinning as a organic thinning hair therapy. One of the herbal remedies producing healthcare head lines will be Saw Palmetto. Although most studies regarding Saw palmetto extract happen to be for your management of prostatic disease, more modern numerous studies have been carried out about its effectiveness for hair thinning. The actual plant has been seen as to operate in eliminating benign prostatic disease by lowering degrees of Dihydrotestosterone, the industry known cause of androgenic alopecia, the medical phrase regarding man or woman routine hair loss. While there isn't any clinical trials supporting this herb's usefulness being a normal hair thinning treatment, there is certainly some dependable investigation proving that it could decrease androgen exercise within
Normal Thinning hair Therapy The particular Dropped Art associated with Head of hair Repair
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
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
Nuviante Hair Reviews has been turned out to be the most proficient approach to build the development, quality and repair your hair. You are never to more youthful to begin encountering male pattern baldness, notwithstanding for ladies it can turn into an issue. Numerous individuals have a go at all that they can, for example, changing the eating regimen, utilizing certain hair items and a great deal all the more, yet nothing will give you precisely what you are searching for, nothing appears to work, as of not long ago! With an all normal and east to utilize supplement, you will be ready to understand that basic hair development you fancy, with thicker hair and much more grounded also. While you are cleaning up and you are beginning to see more hair is than ordinary, you are beginning to see your hair turn out to be flimsy, than you require Nuviante Hair Growth Treatment. Nuviante Hair Care is an energizing new hair development supplement that is taking the business sector by tempest. With such a variety of attempting it and see compelling accomplishment with it, they are beginning to enlighten everybody they know regarding it. On the off chance that you are somebody that has battled with male pattern baldness or simply the powerlessness to become out your hair, then you have gone to the opportune spot with this best hair growth product Nuviante Hair Trials. Nuviante Hair Care is one of the leading hair loss treatments in the form of supplement consumption. Nuviante Hair Growth provides the basic minerals and nutrients to our hair for proper growth and stability of our hair. As it is clinically proven and fortified by Trichology as to complete assurance of hair treatment by stabilizing proper long hair on our scalp and blocks DHT through naturally ingredients it helps to regenerate hair follicles by its treatment o0f nourishment from top layer to0 deep hair root level. Although it’s a complete solution to all your hair related problem. Nuviante spray is one of the most advance product to cures hair loss. It’s all ingredients are 100 percent original and verified by the many well know scientists of various laboratories. This product claims to provide the various benefits like strengthening of hair, regrow hairs, restore the damage hairs, 10 years younger look and prevent from premature hair whitening. Nuviante Hair Growth Treatment has no side effect because it is free from chemicals and fillers. Nuviante Hair Trials is tested in reputed laboratories by many well-known scientists, also its all ingredients aretruly outstanding and 100 percent original. Keep this spray with you always so that for any kind of occasion your hairs are always ready without need to go to saloon and spending much amount. Always make sure that use it as directed and don’t overdo.
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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.
Peter Black (Living with a Brain Tumor: Dr. Peter Black's Guide to Taking Control of Your Treatment)
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.
Sarah Ballantyne (The Paleo Approach: Reverse Autoimmune Disease, Heal Your Body)
Managing patients first with triple therapy and switching to a biologic plus methotrexate in those who do not have an adequate response may be more cost-effective, without adversely affecting clinical outcomes. A recent study did not find a difference between biologics and triple therapy in time to return to work ( 2 ). Cost-effectiveness trials and long-term follow-up studies are needed to assess the durability of intermediate outcomes (such as disease activity) with patient-centered outcomes.
Anonymous
molecularly targeted agents into the treatment of early-stage NSCLC. At this time, however, such an approach cannot be recommended outside a clinical trial. In the NCI-C JBR.19 trial, which was terminated early when gefitinib lost its U.S. Food and Drug Administration (FDA) approval, administration of the EGFR inhibitor gefitinib after resection of stage I to III NSCLC did not improve OS. Surprisingly, a subset analysis of patients with tumors harboring activating EGFR mutations, a population expected to derive particular benefit from such an approach, suggested the possibility of a detrimental effect from gefitinib. Similarly, the use of antiangiogenic agents and ALK inhibitors after surgery for advanced disease remains investigational.
Anonymous
Clip This Article on Location 1397 | Added on Monday, September 1, 2014 4:10:39 PM REVIEW & OUTLOOK An $8.3 Billion Rebuke to the FDA Roche buys a drug approved in Europe but not in America. 359 words Amid this summer's M&A fever, Roche's agreement Monday to buy the San Francisco biotech InterMune deserves special notice. The tie-up is an $8.3 billion guided missile into the fortified bunker that is the Food and Drug Administration. InterMune has never turned a profit in 16 years of existence and other than its clinical expertise the company holds a single asset: an idea for treating a lethal lung disorder called idiopathic pulmonary fibrosis with no known cause, cure or approved therapy—at least in the U.S. An InterMune drug called pirfenidone that slows the progression of irreversible lung scarring is on the market in Europe, Japan, Canada and even China. Bloomberg News But the FDA refused to approve pirfenidone in 2010, despite the 40,000 Americans who are killed annually by lung fibrosis and a positive recommendation from its outside scientific advisory committee. The agency brass claimed the evidence was statistically unsatisfactory, when one clinical trial was inconclusive but another showed strong benefits such as improved lung function. The results of the third trial the FDA ordered were reported earlier this year and confirmed that pirfenidone is even more of a treatment advance than it seemed in 2010, and may prolong life. The agency is expected, finally, to approve the medicine in November. Roche is paying a 38% premium over Friday's closing share price, and 63% over trading before the news of InterMune's corporate suitors broke a few weeks ago. The deal is a big vote of confidence in pirfenidone, not least because a rival lung fibrosis drug is awaiting U.S. approval. Then again, maybe that drug's maker, the German pharmaceutical consortium Boehringer Ingelheim, will have the same FDA experience as InterMune. The Roche deal is a tacit reprimand to the FDA's unscientific and uncompassionate—and wrong—2010 defenestration. Amid medical ambiguity about effectiveness, the humane option is to allow a drug to come to patients and follow on with more research, in particular for a drug with few side effects. Pulmonary fibrosis is a protracted death sentence of three to five years. The FDA denied tens of thousands of dying people better and possibly longer lives in the time they had left. ==========
Anonymous
Finally, the results of a randomized clinical trial of more than 1,000 patients, published in the June 2012 issue of Archives of Internal Medicine, found that women experienced a disproportionate level of extreme fatigue and decreased energy levels after taking statin medications to lower their cholesterol. So if you are a mother or a career woman taking statins, don’t assume it’s your busy life that’s zapped you of energy; it might be those cholesterol pills prescribed to supposedly make you healthier. At the very least, all these studies make it clear that it’s not only worth taking a closer look at the evidence, it’s worth asking if women should be lowering their cholesterol at all.
Jimmy Moore (Cholesterol Clarity: What the HDL is Wrong with My Numbers?)
From the earliest clinical trials in the 1940s, in which diets high in polyunsaturated fats were found to raise mortality from cancer, to these more recent “discoveries” that they contain highly toxic oxidation products, polyunsaturated oils have been problematic for health.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
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.
Gary Taubes (Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control, and Disease)
Big clinical trials have to be judged on their inherent strength but, if they contradict basic science, they have an obligation to explain why. And science is continuous with common sense. It doesn’t matter how many statistical tests you have, if the results violate common sense, it is unlikely to be science.
Richard David Feinman (The World Turned Upside Down: The Second Low-Carbohydrate Revolution)
due to the fact that drug companies have limited interest in sponsoring clinical trials in this area, due to a limited potential for profit. There is little to no money to be made from essential oils within the pharmaceutical industry, as they are natural products derived from natural sources, and therefore, are not patentable. Patents on drug design and manufacture are the number one source of revenue in the pharmaceutical industry.
Amy Joyson (Essential Oils: The Complete Guide: Essential Oils For Beginners, Aromatherapy And Essential Oil Recipes)
There are eighteen million AIDS orphans in Africa right now,”  Joel said.               “Joel, with HIV came millions, billions of dollars worth of research grants, clinical trials, drugs, jobs, and money.  It turned out to be bigger and better than any of us ever dreamed it could.  A true pandemic.
Hunt Kingsbury (Book of Cures (A Thomas McAlister Adventure 2))
This is not science fiction. Around the world, 50,000 men with prostate cancer have been treated with focused ultrasound. Over 22,000 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, arthritis, and hypertension are inching forward at over 225 research sites around the world.
John Grisham (The Tumor)
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
Michael Greger (How Not to Die: Discover the Foods Scientifically Proven to Prevent and Reverse Disease)
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.
Jo Marchant (Cure: A Journey into the Science of Mind Over Body)
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.
John Grisham (The Tumor)
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.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
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,
John Grisham (The Tumor)
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
David Ludwig (Always Hungry?: Conquer cravings, retrain your fat cells and lose weight permanently)
Every clinical trial receiving funding from the National Institutes of Health and other federal agencies is listed at clinicaltrials.gov. At the search box for “condition or disease,” simply type “food allergy” and every relevant study will appear.
Kari Nadeau (The End of Food Allergy: The First Program To Prevent and Reverse a 21st Century Epidemic)
Take the case of Jackson Silva, who as a newborn in 2014, started showing signs of pain and was diagnosed with a form of spinal muscular atrophy. When his parents were informed that nothing could be done, they found a clinical trial in Ohio. “Jackson was the third child in the world to receive treatment. And while 90% of children with SMA pass away before the age of two, and 50% pass away before 6 months old, Jackson is still here because of the investigational drug he is receiving. Jackson’s parents want all children with SMA to have access to this drug, not just the lucky few who have been accepted into a clinical trial.”5 For those interested, please visit RightToTry.Org.
Donald Trump Jr. (Liberal Privilege: Joe Biden And The Democrats' Defense Of The Indefensible)
Then came a sudden and nonsensical reversal. The CDC announced on April 7 that there were no approved drugs to treat COVID-19. “Hydroxychloroquine and chloroquine are under investigation in clinical trials” for use on coronavirus patients and “there are no drugs or other therapeutics approved by the US Food and Drug Administration to prevent or treat COVID-19,” the agency’s updated guidelines stated. It was downright bizarre to single out HCQ like this, I thought. I began to suspect some kind of behind-the-scenes decision had been made to sideline the drug.
Simone Gold (I Do Not Consent: My Fight Against Medical Cancel Culture)
RevSkin Cream Canada With this age being tagged because the age of contamination, it's vital to ascertain that your product selection is sweet which you it delivers lead you to the expected ageless path of youth. Best Wrinkle Cream has got to be natural in its formulation to trigger natural benefits. Right off the bat, you would like a product that has been tested. check out a product's claims to ascertain Wrinkle Cream Reviews if it's produced consistent leads to a testing environment. These clinical trials will help to determine an optimal amount of each ingredient, and prove that it works during a controlled environment. Because otherwise, there's no way of knowing whether a product will live up to its advertised claims or, worse, if it'd even be harmful for your skin!
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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.
Michael Greger (How Not to Diet)
As I implied earlier, we can only know if a recommended intervention is a success in preventive medicine if it causes more good than harm, and that can be established only with randomized, controlled clinical trials. Moreover, it’s not sufficient to establish that the proposed intervention reduces the rate of only one disease—say, heart disease. We also have to establish that it doesn’t increase the incidence of other diseases, and that those prescribed the intervention stay healthier and live longer than those who go without it. And because the diseases in question can take years to develop, enormous numbers of people have to be included in the trials and then followed for years, or perhaps decades, before reliable conclusions can be drawn.
Gary Taubes (Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control, and Disease)
There is an affordable laser treatment device that can be used at home with a headset that emits near infrared light through diodes placed on the scalp and inside the nostril called Vielight. They are conducting a clinical trial with 228 participants across North America to see what it does for Alzheimer’s. If someone I love was suffering from Alzheimer’s right now, I wouldn’t want to have to wait for this trial to be over before getting the device. The risk of allowing Alzheimer’s to progress is much higher than the risk of trying it out. Devices that use light on the brain range from $200 to many thousands of dollars.
Dave Asprey (Super Human: The Bulletproof Plan to Age Backward and Maybe Even Live Forever)
More recently, a double-blind pilot clinical trial revealed that six months of a 15 milligram daily dose of nicotine is beneficial for those with milder forms of cognitive impairment.23 And the body of research is growing. Nicotine may also help those with Parkinson’s and Alzheimer’s due to its ability to work as an antioxidant in the brain.24
Dave Asprey (Super Human: The Bulletproof Plan to Age Backward and Maybe Even Live Forever)
Our belief in the dangers of salt in the diet is once again based on Geoffrey Rose’s philosophy of preventive medicine. Public-health authorities have continued to recommend that we all eat less salt because they believe that any benefit to the individual, no matter how clinically insignificant, will have a significant impact on the public health. But this evades the scientific question that still has to be answered: if excessive salt consumption does not cause hypertension, as these clinical trials suggest it does not, then what does? Moreover, embracing a suspect public-health pronouncement serves to inhibit rigorous scientific research.
Gary Taubes (Good Calories, Bad Calories: Challenging the Conventional Wisdom on Diet, Weight Control, and Disease)
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.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
There are two types of supplementary inositol, which have different effects. D-chiro-inositol improves insulin sensitivity throughout the body. Myo-inositol improves insulin and FSH signaling inside the ovary, thereby improving ovarian function and promoting healthy ovulation. The inositol formula used in the clinical trials is a combined supplement of myo-inositol and d-chiro-inositol in a 40:1 ratio, which corresponds to the body’s normal ratio. The standard dose is 2000 to 4000 mg and is generally safe for long-term use.
Lara Briden (Period Repair Manual: Natural Treatment for Better Hormones and Better Periods)
Clinical trials needed efficiency, speed, and a focus on results, so differentiating against marketing agencies was easy. I knew there were some trial recruitment companies, but they tended to shy away from rare diseases, chucking those patients as too hard to find.
Sandra Shpilberg (New Startup Mindset: Ten Mindset Shifts to Build the Company of Your Dreams)
Salmon calcitonin (SCT) has been an available therapeutic agent for over 30 years. The analgesic properties of SCT have been documented in several prospective clinical trials. Studies that
Boukezzoula Mohamed Amine (Coccyx Pain Relief : Say Goodbye To Your Suffering: Coccydynia : Quick Relief For Tail Bone Pain)
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This demand was further supported by industry fundamentals: 80 percent of emerging biotech companies were developing treatments in rare disease or oncology, our areas of focus. If only a portion of these came to Seeker Health for clinical trial enrollment, we would be just fine.
Sandra Shpilberg (New Startup Mindset: Ten Mindset Shifts to Build the Company of Your Dreams)
More high-quality clinical trials are required to confirm this, but current evidence suggests that telling diabetics to reduce their salt intake to low levels could actually be harming them.
Tim Spector (Spoon-Fed: Why Almost Everything We’ve Been Told About Food is Wrong)
While miltefosine was a newer drug and could be taken in pill form, he didn’t want to use it. And besides, there was none available.* There had been too few clinical trials to make him comfortable with it, and in one trial in Colombia it seemed to be ineffective against L. braziliensis. He also said you never really knew what kind of side effects might pop up until at least ten thousand people had taken a drug, and miltefosine had not reached that benchmark. He had had long experience with amphotericin B, and it produced an approximately 85 percent remission rate, which was about “as good as it gets” in any drug treatment.
Douglas Preston (The Lost City of the Monkey God)
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.
Maria Konnikova (The Biggest Bluff: How I Learned to Pay Attention, Master Myself, and Win)
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.
Maria Konnikova (The Biggest Bluff: How I Learned to Pay Attention, Take Control and Win)
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.
Malcolm Hooper
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.
Tanya Marlow
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
Michael Matthews (Bigger Leaner Stronger: The Simple Science of Building the Ultimate Male Body)
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.
Kathleen McAuliffe (This Is Your Brain On Parasites: How Tiny Creatures Manipulate Our Behavior and Shape Society)
Only one person was conspicuously missing from the (American Society of Clinical Oncology, ASCO) party - Dennis Slamon. Having spent the afternoon planning the next phase of Herceptin trials with breast oncologists at ASCO, Slamon had jumped into his rundown Nissan and driven home.
Siddhartha Mukherjee (The Emperor of All Maladies: A Biography of Cancer)
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.
John Grisham (The Tumor)
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.
James P. Womack (Lean Thinking: Banish Waste And Create Wealth In Your Corporation)