Fda Quotes

We've searched our database for all the quotes and captions related to Fda. Here they are! All 100 of them:

I mean, how do you know if people are good for you or not? It's not like they come with an FDA approved sticker or anything.
Michael Thomas Ford (Suicide Notes)
Love is like a corn-dog popsicle, and I’m on the Most Wanted list. Unfortunately it’s by the government, specifically the FDA, and not by women.
Jarod Kintz (Love quotes for the ages. Specifically ages 18-81.)
If end-of-life discussions were an experimental drug, the FDA would approve it.
Atul Gawande (Being Mortal: Medicine and What Matters in the End)
Unfortunately, beer was only a short-term answer. And head transplants had yet to be approved by the FDA.
J.R. Ward (Covet (Fallen Angels, #1))
But perhaps the most alarming ingredient in a Chicken McNugget is tertiary butylhydroquinone, or TBHQ, an antioxidant derived from petroleum that is either sprayed directly on the nugget or the inside of the box it comes in to "help preserve freshness." According to A Consumer's Dictionary of Food Additives, TBHQ is a form of butane (i.e. lighter fluid) the FDA allows processors to use sparingly in our food: It can comprise no more than 0.02 percent of the oil in a nugget. Which is probably just as well, considering that ingesting a single gram of TBHQ can cause "nausea, vomiting, ringing in the ears, delirium, a sense of suffocation, and collapse." Ingesting five grams of TBHQ can kill.
Michael Pollan (The Omnivore's Dilemma: A Natural History of Four Meals)
What about the FDA? Please, are you serious? Back then the FDA was one of the most underfunded, mismanaged organizations in the country. I think they were still high-fiving over getting Red No. 218 out of M&Ms.
Max Brooks (World War Z: An Oral History of the Zombie War)
The Law waits for you to stumble on a mode of being, a soul different from the FDA-approved purple-stamped standard dead meat — & as soon as you begin to act in harmony with nature the Law garottes & strangles you — so don’t play the blessed liberal middleclass martyr — accept the fact that you’re a criminal & be prepared to act like one.
Hakim Bey (TAZ: The Temporary Autonomous Zone, Ontological Anarchy, Poetic Terrorism (New Autonomy))
Most USA citizens never realize that the systems of public protection are essentially useless until they try to use them. At that point they learn the hard way that government agencies like OSHA, FCC, FDA, police internal affairs, disability, and the like do not work for them.
Steven Magee
end-of-life discussions were an experimental drug, the FDA would approve it.
Atul Gawande (Being Mortal: Medicine and What Matters in the End)
The FDA and the EPA are supposed to be protecting us, not the people who make the poison.
Kenneth Eade (An Involuntary Spy (Involuntary Spy #1))
What the FDA fails to include is whether it’s okay to inject multiple vaccines simultaneously.
James Morcan (Vaccine Science Revisited: Are Childhood Immunizations As Safe As Claimed? (The Underground Knowledge Series, #8))
Though the industrial logic that made feeding cattle to cattle seem like a good idea has been thrown into doubt by mad cow disease, I was surprised to learn it hadn't been discarded. The FDA ban on feeding ruminant protein to ruminants makes an exception for blood products and fat; my steer will probably dine on beef tallow recycled from the very slaughterhouse he's heading to in June.
Michael Pollan (The Omnivore's Dilemma: A Natural History of Four Meals)
To speak only of food inspections: the United States currently imports 80% of its seafood, 32% of its fruits and nuts, 13% of its vegetables, and 10% of its meats. In 2007, these foods arrived in 25,000 shipments a day from about 100 countries. The FDA was able to inspect about 1% of these shipments, down from 8% in 1992. In contrast, the USDA is able to inspect 16% of the foods under its purview. By one assessment, the FDA has become so short-staffed that it would take the agency 1,900 years to inspect every foreign plant that exports food to the United States.
Marion Nestle (Pet Food Politics: The Chihuahua in the Coal Mine)
doctors & druggists wash each other's hands
Geoffrey Chaucer (Canterbury Tales)
Food safety oversight is largely, but not exclusively, divided between two agencies, the FDA and the USDA. The USDA mostly oversees meat and poultry; the FDA mostly handles everything else, including pet food and animal feed. Although this division of responsibility means that the FDA is responsible for 80% of the food supply, it only gets 20% of the federal budget for this purpose. In contrast, the USDA gets 80% of the budget for 20% of the foods. This uneven distribution is the result of a little history and a lot of politics.
Marion Nestle (Pet Food Politics: The Chihuahua in the Coal Mine)
If a drug failed as often and had as many side effects as western marriage, the FDA probably would not approve it.
Ron Davison (The Fourth Economy: Inventing Western Civilization)
Ironically, the very advances that represent all that is modern in the world—hand sanitizers, treated water, factory farming—have created their own set of diseases. For example, triclosan—an antibacterial chemical used in many soaps and hand sanitizers—has been shown to kill human cells,26 and even the FDA admits it acts as an endocrine disruptor in animals.27 When combined with chlorinated water, it produces chloroform28—a probable carcinogen according to the EPA.29
Joseph Mercola (Effortless Healing: 9 Simple Ways to Sidestep Illness, Shed Excess Weight, and Help Your Body Fix Itself)
The result: those who saw a palliative care specialist stopped chemotherapy sooner, entered hospice far earlier, experienced less suffering at the end of their lives—and they lived 25 percent longer. In other words, our decision making in medicine has failed so spectacularly that we have reached the point of actively inflicting harm on patients rather than confronting the subject of mortality. If end-of-life discussions were an experimental drug, the FDA would approve it.
Atul Gawande (Being Mortal: Illness, Medicine and What Matters in the End (Wellcome Collection))
The two most trusted medical journals in the United States had published incorrect, manufacturer-biased reports about major drugs. The FDA knew that both articles had misrepresented the data but did not correct the misleading information.
John Abramson (Sickening: How Big Pharma Broke American Health Care and How We Can Repair It)
So what steps can a regulator take when it has established that there is a problem? In very extreme cases it can remove a drug from the market (although in the US, technically drugs usually stay on the market, with the FDA advising against their use). More commonly it will issue a warning to doctors through one of its drug safety updates, a ‘Dear Doctor’ letter, or by changing the ‘label’ (confusingly, in reality, a leaflet) that comes with the drug. Drug-safety updates are sent to most doctors, though it’s not entirely clear whether they are widely read. But, amazingly, when a regulator decides to notify doctors about a side effect, the drug company can contest this, and delay the notice being sent out for months, or even years.
Ben Goldacre (Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients)
The sad irony here is that the FDA, which does not regulate fluoride in drinking water, does regulate toothpaste and on the back of a tube of fluoridated toothpaste … it must state that “if your child swallows more than the recommended amount, contact a poison control center.” The amount that they’re talking about, the recommended amount, which is a pea-sized amount, is equivalent to one glass of water. The FDA is not putting a label on the tap saying don’t drink more than one glass of water. If you do, contact a poison center… There is no question that fluoride — not an excessive amount — can cause serious harm.
Paul Connett (The Case Against Fluoride: How Hazardous Waste Ended Up in Our Drinking Water and the Bad Science and Powerful Politics That Keep It There)
health agencies had put regulatory capture on steroids. The CDC, for example, owns 57 vaccine patents1 and spends $4.9 of its $12.0 billion-dollar annual budget (as of 2019) buying and distributing vaccines.2,3 NIH owns hundreds of vaccine patents and often profits from the sale of products it supposedly regulates. High level officials, including Dr. Fauci, receive yearly emoluments of up to $150,000 in royalty payments on products that they help develop and then usher through the approval process.4 The FDA receives 45 percent of its budget from the pharmaceutical industry, through what are euphemistically called “user fees.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
The day the FDA rule came out, there were partially hydrogenated oils in some 42,720 packaged food products, including 100 percent of crackers, 95 percent of cookies, 85 percent of breading and croutons, 75 percent of baking mixes, 70 percent of chip-type snacks, 65 percent of margarines, and 65 percent of pie shells, frosting, and chocolate chips.
Nina Teicholz (The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet)
Dr. Margaret Chan, Director-General of the World Health Organization, recently warned that we may be facing a future in which many of our miracle drugs no longer work. She stated, “A post-antibiotic era means, in effect, an end to modern medicine as we know it. Things as common as strep throat or a child’s scratched knee could once again kill.”147 We may soon be past the age of miracles. The director-general’s prescription to avoid this catastrophe included a global call to “restrict the use of antibiotics in food production to therapeutic purposes.” In other words, only use antibiotics in agriculture to treat sick animals. But that isn’t happening. In the United States, meat producers feed millions of pounds of antibiotics each year to farm animals just to promote growth or prevent disease in the often cramped, stressful, and unhygienic conditions of industrial animal agriculture. Yes, physicians overprescribe antibiotics as well, but the FDA estimates that 80 percent of the antimicrobial drugs sold in the United States every year now go to the meat industry.
Michael Greger (How Not to Die: Discover the Foods Scientifically Proven to Prevent and Reverse Disease)
And recall, it was the FDA that approved Vioxx, which led to more than sixty thousand deaths.
Jim Marrs (Population Control: How Corporate Owners Are Killing Us)
If you would like the FDA to keep a sharper eye on health claims on food products, you need to convey that sentiment to your congressional representatives.
Marion Nestle (What to Eat)
In fact, these days, it was practically a rite of passage for each new head of the FDA to sit for a lengthy interview with the publisher of the Medical Tribune, Arthur Sackler.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
In the United States, the FDA has approved HCQ without limitation for 65 years, meaning that physicians can prescribe it for any off-label use.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
So without alerting the FDA, much less asking for permission, Purdue started manufacturing MS Contin at a plant in New Jersey and offered it for sale in October 1984.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
NuFace Trinity , NuFace Trinity is a new FDA-cleared, revolutionary device with interchangeable treatment heads that gives you a variety of spa-quality treatments at home
NuFace Trinity
The FDA just ordered them off the market. The glaze is supposed to be poison—provided you drink at least forty cups of tea out of one of them every day of your life for twenty years.
Frederik Pohl (Man Plus (Man Plus #1))
Hammond shook his head sadly. “Yet, you’ll remember,” he said, “the original genetic engineering companies, like Genentech and Cetus, were all started to make pharmaceuticals. New drugs for mankind. Noble, noble purpose. Unfortunately, drugs face all kinds of barriers. FDA testing alone takes five to eight years—if you’re lucky. Even worse, there are forces at work in the marketplace. Suppose you make a miracle drug for cancer or heart disease—as Genentech did. Suppose you now want to charge a thousand dollars or two thousand dollars a dose. You might imagine that is your privilege. After all, you invented the drug, you paid to develop and test it; you should be able to charge whatever you wish. But do you really think that the government will let you do that? No, Henry, they will not. Sick people aren’t going to pay a thousand dollars a dose for needed medication—they won’t be grateful, they’ll be outraged. Blue Cross isn’t going to pay it. They’ll scream highway robbery. So something will happen. Your patent application will be denied. Your permits will be delayed. Something will force you to see reason—and to sell your drug at a lower cost. From a business standpoint, that makes helping mankind a very risky business. Personally, I would never help mankind.
Michael Crichton (Jurassic Park (Jurassic Park, #1))
In other words, the FDA is concerned only with acute toxins in food (those chemicals that kill you immediately), not chronic toxins, which kill you slowly by promoting chronic disease.
Robert H. Lustig (Fat Chance: Beating the Odds Against Sugar, Processed Food, Obesity, and Disease)
Brace yourselves, girls: Soda is liquid Satan. It is the devil. It is garbage. There is nothing in soda that should be put into your body. For starters, soda’s high levels of phosphorous can increase calcium loss from the body, as can its sodium and caffeine. [Cousens, Conscious Eating, 475] You know what this means—bone loss, which may lead to osteoporosis. And the last time we checked, sugar, found in soda by the boatload, does not make you skinny! Now don’t go patting yourself on the back if you drink diet soda. That stuff is even worse. Aspartame (an ingredient commonly found in diet sodas and other sugar-free foods) has been blamed for a slew of scary maladies, like arthritis, birth defects, fibromyalgia, Alzheimer’s, lupus, multiple sclerosis, and diabetes.2 When methyl alcohol, a component of aspartame, enters your body, it turns into formaldehyde. Formaldehyde is toxic and carcinogenic (cancer-causing). 3 Laboratory scientists use formaldehyde as a disinfectant or preservative. They don’t fucking drink it. Perhaps you have a lumpy ass because you are preserving your fat cells with diet soda. The Food and Drug Administration (FDA) has received more complaints about aspartame than any other ingredient to date.4 Want more bad news? When aspartame is paired with carbs, it causes your brain to slow down its production of serotonin.5 A healthy level of serotonin is needed to be happy and well balanced. So drinking soda can make you fat, sick, and unhappy.
Rory Freedman (Skinny Bitch: A No-Nonsense, Tough-Love Guide for Savvy Girls Who Want to Stop Eating Crap and Start Looking Fabulous!)
Our analyses of the FDA data showed relatively little difference between the effects of antidepressants and the effects of placebos. Indeed, the effects were so small that they did not qualify as clinically significant. The drug companies knew how small the effect of their medications were compared to placebos, and so did the FDA and other regulatory agencies. The companies found various ways to make the data seem more favorable to their products, and the FDA helped them keep their negative data secret. In fact, in some instances, the FDA urged the companies to keep negative data hidden, even when the companies wanted to reveal them. My colleagues and I hadn't really discovered anything new. We had merely revealed their 'dirty little secret'.
Irving Kirsch (The Emperor's New Drugs: Exploding the Antidepressant Myth)
DON’T BE FOOLED BY ADVERTISING JARGON: The terms “all-natural” “fresh,” and “no additives” carry little weight. Since these terms are loosely regulated by the FDA, they are tossed around like dollar bills in a strip club.
Rory Freedman Freedman
Instead of citing scientific studies to justify mandates for masks, lockdowns, and vaccines, our medical rulers cite WHO, CDC, FDA, and NIH—captive agencies that are groveling sock puppets to the industries they regulate.
Joseph Mercola (The Truth About COVID-19: Exposing The Great Reset, Lockdowns, Vaccine Passports, and the New Normal)
The thing that bugs me is that the people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day. —Herbert Lay, M.D., former FDA Commissioner
Kevin Trudeau (Natural Cures "They" Don't Want You To Know About)
As the Mayo Clinic rather indelicately put it, “Most people are infected with Salmonella by eating foods that have been contaminated by feces.”102 How does it get there? In slaughter plants, birds are typically gutted by a metal hook, which too often punctures their intestines and can expel feces onto the flesh itself. According to the latest national FDA retail-meat survey, about 90 percent of retail chicken showed evidence of contamination with fecal matter.
Michael Greger (How Not to Die: Discover the Foods Scientifically Proven to Prevent and Reverse Disease)
Thus, if any FDA-approved drug like hydroxychloroquine (or ivermectin) proved effective against COVID, pharmaceutical companies would no longer be legally allowed to fast-track their billion-dollar vaccines to market under Emergency Use Authorization.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
a variation of the anesthetic ketamine (developed in 1962 and nicknamed “special K” by club kids in the ’80s and ’90s) was recently approved by the FDA for use in treatment-resistant depression, which affects 20 percent or more of people with the disorder. It
Susannah Cahalan (The Great Pretender: The Undercover Mission That Changed Our Understanding of Madness)
Death by drugs is now a national problem, but the crisis began as an epidemic of overprescribed painkillers in the distressed communities that were least likely to muster the resources to fight back. It erupted in rural fishing villages, coal communities, and mill towns—because Purdue’s sales strategy was to convince doctors that the nation’s injured miners and factory workers were better and more safely served by OxyContin than its weaker competitors. The company even maneuvered to convince the FDA to back this bogus claim.
Beth Macy (Raising Lazarus: Hope, Justice, and the Future of America's Overdose Crisis)
According to economist Dr. Paul Craig Roberts, who served as assistant secretary of the treasury in the Reagan administration, Dick Cheney used his two terms as vice president to fill environmental agencies, including the FDA, with corporate-friendly executives. Jeffrey
Jim Marrs (Population Control: How Corporate Owners Are Killing Us)
The FDA does not exist to protect you. They do no testing on any products. The FDA is a system that protects a person or person(s) from selling a product or products that could cause someone very important to lose money to others who may use that money and power to due them harm.
James Thomas Kesterson Jr
In other words, our decision making in medicine has failed so spectacularly that we have reached the point of actively inflicting harm on patients rather than confronting the subject of mortality. If end-of-life discussions were an experimental drug, the FDA would approve it. Patients
Atul Gawande (Being Mortal: Medicine and What Matters in the End)
To get products approved, firms had to create applications to prove that medicines were ‘”safe and effective”, meaning more effective than doing nothing at all. That standard was never refined to include the more modern question: Is the product more effective than the dozens of other treatments for a particular conditions that are already on the market? Equally important, the FDA yardstick for approval did not include any consideration of price of cost-effectiveness – a metric that virtually all other countries now use as they consider admitting new drugs to their formula.
Elisabeth Rosenthal (An American Sickness: How Healthcare Became Big Business and How You Can Take It Back)
The FDA finally relented on Saturday, February 29, and announced that it would allow non-government labs to use their own tests as they waited to get Emergency Use Authorizations. That Monday, Greninger’s lab tested thirty patients. Within a few weeks, it would be testing more than 2,500 a day.
Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race)
...Only the big food manufacturers have the wherewithal to secure FDA-approved health claims for their products and then trumpet them to the world. Generally, it is the products of modern food science that make the boldest health claims, and these are often founded on incomplete and often bad science.
Michael Pollan (Food Rules: An Eater's Manual)
– 산도스 졸피뎀 정과 라멥틸 정, 9월부터 일동제약 단독 판매 – 안전성 승인된 정신신경용제 제네릭 의약품의 폭넓은 국내 공급 교두보 마련 한국산도스(대표 윤소라)가 일동제약(대표 이정치)과 수면진정제 산도스 졸피뎀 정, 항전간제 라멥틸 정 등 2개 품목에 대한 판매제휴 협약을 체결한다고 26일 밝혔다. 한국산도스는 일동제약과의 이번 협력으로 국내 환자들에게 정신신경용제 제네릭 의약품을 폭넓게 공급한다는 방침이다. 수면안전 진정제{수면제sandos zolpidem} {수면제sandos zolpidem}구입상담문의 go~ ★카톡:kodak8★텔레그램:Komen68★ p08.jpg수면진정제 ‘산도스 졸피뎀 정(Zolpidem 10mg)은 비 벤조디아제핀(Benzodiazepine)계 수면제로, 수면작용에 관여하는 수용체에만 특이적으로 작용하여 불면증 치료에 효과적이다. 근 이완, 항경련 효과 등의 부작용이 적고, 자연생리 수면구조를 그대로 유지시켜 주기 때문에 일상생활에 영향을 미치지 않는다. 광고 이 광고 신고 항전간제 ‘라멥틸 정(Lamotrigine 25/50/100mg)은 페닐트라진(Phenyltriazine) 유도체로 전압-의존성 나트륨 채널을 억제하여 신경세포막을 안정화시켜 간질과 양극성 장애에 효과적이다. 또한 글루타메이트(Glutamate)와 아스파르테이트(Asparatate)등의 흥분성 신경전달물질의 분비를 감소시켜 주며, 딸기향의 확산정(Dispersible Tablet)으로 경구투여가 힘든 환자 및 소아에 편리하게 투여가 가능하다. 두 의약품 모두 FDA(미국식품의약품안전청, Food and Drug Administration)와 EMEA(유럽연합식약청, European Medicines Agency)의 승인을 받아 효과와 안전성을 입증 받았으며, 다음달 1일부터 일동제약의 단독 판매가 시작될 예정이다. ^^바로구입가기^^ ↓↓아래 이미지 사이트 클릭↓↓ ★카톡:kodak8★텔레그램:Komen68★ 1289376735134_sandoz1.jpg한국산도스 윤소라 대표는 “지금까지는 한국산도스의 기업 신뢰 및 제품 인지도 상승을 위해 노력해왔다. 이제는 고품질 의약품을 폭넓게 제공하는 것을 목표로, 국내 시장의 제네릭 보급 및 점유율 확대에 박차를 가할 예정이다”며, “한국산도스의 우수한 제네릭 의약품을 더 많은 환자들이 사용할 수 있도록 공동의 목적을 가진 국내 제약사와의 제휴를 미루지 않을 생각이다”라고 말했다.
한국 산도스 졸피뎀{sandos zolpidem}효과 성분★카톡:kodak8★텔레그램:Komen68★졸피뎀판매,수면제판매,스틸녹스판매,
The drugs became scarce, which prompted state correctional authorities to obtain them illegally, without complying with FDA rules that regulate the interstate sale and transfer of drugs. Drug raids of state correctional facilities were a bizarre consequence of this surreal drug dealing to carry out executions.
Bryan Stevenson (Just Mercy: A Story of Justice and Redemption)
They “duped the FDA, saying OxyContin lasted twelve hours,” Moore said. “They lied about the addictive properties. And they did all this to grow the opioid market, to make it okay to jump in the water. Then some of these other companies, they saw that the water was warm. And they said, ‘Okay, we can jump in, too.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
And here’s the kicker: food manufacturers are using a gasoline additive known as hexane to process soy products (and some vegetable oils). Soybeans are soaked in large vats of hexane to assist in the extraction of substances such as protein and oils from them. An independent lab has found hexane residue in soy-based foods, but the FDA does not require any testing for hexane, even in baby foods. It is used by the food industry because it is cheap to do so and because the FDA lets them get away with it. The soy industry is incredibly powerful and influential. The U.S. Environmental Protection Agency lists hexane, incidentally, as a hazardous chemical.
Nora T. Gedgaudas (Primal Body, Primal Mind: Beyond Paleo for Total Health and a Longer Life)
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)
Purdue filed papers with the FDA, asking the agency to refuse to accept generic versions of the original formulation of OxyContin—the version the company had been selling all these years—on grounds that it was unsafe. The company said that it was voluntarily withdrawing the original formulation from the market for reasons “of safety.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
The harm done by the FDA does not result from defects in the people in charge—unless it be a defect to be human. Many have been able and devoted civil servants. However, social, political, and economic pressures determine the behavior of the people supposedly in charge of a government agency to a far greater extent than they determine its behavior. No doubt there are exceptions, but they are rare—almost as rare as barking cats. That does not mean that effective reform is impossible. But it requires taking account of the political laws governing the behavior of government agencies, not simply berating officials for inefficiency and waste or questioning their motives and urging them to do better. The
Milton Friedman (Free to Choose: A Personal Statement)
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)
When Iran starts to regulate USA nuclear facilities, it will be a step in the right direction for the safety and security of 300 million people.
Steven Magee
I speak the truth in a society of lies.
Steven Magee
Dr. Fauci worked with Facebook’s Mark Zuckerberg and other social media sites to muzzle discussion of any remedies. FDA sent a letter of warning that N-acetyle-L-cysteine (NAC) cannot be lawfully marketed as a dietary supplement, after decades of free access on health food shelves, and suppressed IV vitamin C, which the Chinese were using with extreme effectiveness.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
With the Pure Food and Drug Act of 1906, the United States cracked down on false and misleading labels, unsafe ingredients in food, and the adulteration of medical and food products. In 1930, the watchdog bureau became known as the Food and Drug Administration (FDA). Later laws in 1938 covered medical devices and cosmetics, and a 1962 law added scientific rigor to the drug industry.
Lydia Kang (Quackery: A Brief History of the Worst Ways to Cure Everything)
Under Steve Jobs, there's zero tolerance for not performing," its CEO said. At another point, when VLSI Technology was having trouble delivering enough chips on time, Jobs stormed into a meeting and started shouting that they were "fucking dickless assholes." The company ended up getting the chips to Apple on time, and its executives made jackets that boasted on the back, "Team FDA.
Walter Isaacson (Steve Jobs)
The egg industry tells us eggs are good because they are high in protein, but I have already shown you we don’t need the protein, and in fact the FDA does not allow the egg industry to advertise that eggs are a healthy food. Both because even one egg exceeds the recommended daily allowance for cholesterol, and because so many eggs harbor harmful salmonella bacteria, eggs are barely this side of legal.
Garth Davis (Proteinaholic: How Our Obsession with Meat Is Killing Us and What We Can Do About It)
As for Curtis Wright, he had been giving some thought, lately, to leaving the federal government. After the approval for OxyContin went through, he resigned from the FDA. Initially, he joined a small pharmaceutical firm in Pennsylvania called Adolor. But he did not stay long. Barely a year later, he moved on, to a new position at Purdue Pharma, in Norwalk, with a first-year compensation package of nearly $400,000.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
I discovered this tie several years ago when reporting on an FDA source’s tip about the suspected link between antiperspirants and breast cancer. The FDA official told me that the agency was contemplating requiring a breast cancer warning on antiperspirants based on several studies suggesting a possible link. But some inside the FDA felt that industry opposition would be insurmountable. It was an inside debate that would interest many in the public. As I pursued the story, the cosmetics industry wouldn’t do an interview but referred me to the American Cancer Society, which, they assured me, would defend their interests. Indeed, the American Cancer Society was all too happy to agree to appear on camera debunking any idea of a link between antiperspirants and breast cancer. But in my pre-interview with the Cancer Society’s chief doctor, I discovered he hadn’t read—and apparently didn’t know about—the latest peer-reviewed, published studies suggesting a link. That’s when I thought to ask the Cancer Society if it got funding from the cosmetics industry. The answer was a very defensive “Yes.” But the charity wouldn’t disclose how much and said they wouldn’t go through with the on-camera interview unless I agreed not to ask about the antiperspirant industry funding. I forwarded the studies to the American Cancer Society’s doctor. When he did the on-camera interview with me, he reversed his earlier position that had claimed the antiperspirant–breast cancer link was a “myth.” Instead, he answered my questions by deflecting—repeatedly stating, when asked about the latest antiperspirant studies, that women have more important things to focus on, such as getting regular mammograms.
Sharyl Attkisson (Stonewalled: One Reporter's Fight for Truth in Obama's Washington)
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)
FAT FREE, NONFAT, LOW FAT, LIGHT Only in the bizarro world of food labeling can the terms “fat free,” “zero fat,” “no fat,” and “without fat” not necessarily mean that the product in fact has zero grams of fat. In the world according to the FDA, “zero” means anything from actually zero all the way up to half a gram. By this outlandish arithmetic, four servings of “zero fat” food can actually contain close to two grams of fat.
Patrick DiJusto (This Is What You Just Put in Your Mouth?: From Eggnog to Beef Jerky, the Surprising Secrets of What's Inside Everyday Products)
Barbara Moulton who had spent five years as a drug examiner at the FDA before resigning in protest. The agency had “failed utterly” in its task of policing the way prescription drugs were marketed and sold, she testified. Moulton described an environment at the FDA of unrelenting pressure from the drug companies and a culture in which regulators, rather than regulate the drug companies and their products, showed slavish deference to the private sector.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
And so far, their most recent results had been perfect. Their meetings in Germany and Switzerland had gone brilliantly. The testing done in their laboratories there was even more rigorous than what had been done in the States. They were sure now. It was safe. They could move ahead to Phase One Human Trials, as soon as the FDA approved it, which meant giving low doses of the medication to a select number of willing, well-informed subjects, and seeing how they fared.
Danielle Steel (Five Days in Paris)
According to the FDA, there are now more than 80,000 chemicals in commercial use in this country and only 560 of those have ever been tested for human health effects. There is great concern among scientists and researchers about a new synergistic effect from the combination of all of these chemicals forming new chemical compounds within the human body and what the long-term implications might be. It’s no longer speculation that today’s toxic world is taking its toll on the human body.
Peter Greenlaw (Why Diets are Failing Us)
We have determined that an analysis of spontaneous postmarketing adverse events [VAERS reports] reported under section 505(k)(1) of the FDCA [Federal Food, Drug and Cosmetic Act] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
Progressives want to take over all the major industries, from education to health care to energy to automobiles to investment banking to real estate. From Wall Street to Silicon Valley, they want, as my fellow inmates like to say, “the whole enchilada.” This is not to say that progressives intend to seize all that wealth, but they do want to control it. Progressives generally can’t create wealth, so they seek to take it over once it has been created by someone else. They do this through the various agencies of government, such as the IRS, the FBI, the EPA, the FCC, the FDA, the BLM, and HHS. Certainly progressive leaders intend to become fantastically rich while pretending to serve the public good—look at the way the Obamas and the Clintons live—but their ultimate goal isn’t just money: it is also power. Progressives like Obama and Hillary want to wrest control of the levers of society so that they can run things for their own benefit, and do what they want without restraint, above the law.
Dinesh D'Souza (Stealing America: What My Experience with Criminal Gangs Taught Me about Obama, Hillary, and the Democratic Party)
A few days later, the FDA responded by requiring him to do more trials to see if the test he was using inadvertently detected the MERS and SARS viruses, even though they had been dormant for years and he had no samples of those viruses to test. When he called the CDC to see if he could get a sample of the old SARS virus, it refused. “That’s when I thought, ‘Huh, maybe the FDA and the CDC haven’t talked about this at all,’ ” Greninger told reporter Julia Ioffe. “I realized, Oh, wow, this is going to take a while.
Walter Isaacson (The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race)
The CDC, for example, owns 57 vaccine patents1 and spends $4.9 of its $12.0 billion-dollar annual budget (as of 2019) buying and distributing vaccines.2,3 NIH owns hundreds of vaccine patents and often profits from the sale of products it supposedly regulates. High level officials, including Dr. Fauci, receive yearly emoluments of up to $150,000 in royalty payments on products that they help develop and then usher through the approval process.4 The FDA receives 45 percent of its budget from the pharmaceutical industry,
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
Equally as intriguing as the concept of personalized medicine is the proposal to develop the first drugs based on race. Think of the paradox: a classification system constructed centuries ago to enslave people became the portal for the most cutting-edge biomedical advance of the twenty-first century. Predicting drug response based on a patient’s race rather than on genetic traits, says Lawrence Lesco of the FDA’s Center for Drug Evaluation Research, is “like telling time with a sundial instead of looking at a Rolex watch.
Dorothy Roberts (Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-First Century)
hydroxychloroquine in other countries, early-use outpatient treatment would be an important key to interrupting the exponential spread of the virus and minimizing deaths in the United States.)* Nonetheless, five days later, those very same FDA bureaucrats—including FDA commissioner Stephen Hahn and his eventual replacement, Janet Woodcock—completely countermanded the POTUS-Azar-Kadlec order. Instead, on March 28, the FDA issued a rogue directive restricting the use of hydroxychloroquine to the late treatment of hospitalized patients.13
Peter Navarro (In Trump Time: A Journal of America's Plague Year)
In 1994, Friedman wrote a memo marked “Very Confidential” to Raymond, Mortimer, and Richard Sackler. The market for cancer pain was significant, Friedman pointed out: four million prescriptions a year. In fact, there were three-quarters of a million prescriptions just for MS Contin. “We believe that the FDA will restrict our initial launch of OxyContin to the Cancer pain market,” Friedman wrote. But what if, over time, the drug extended beyond that? There was a much greater market for other types of pain: back pain, neck pain, arthritis, fibromyalgia. According to the wrestler turned pain doctor John Bonica, one in three Americans was suffering from untreated chronic pain. If that was even somewhat true, it represented an enormous untapped market. What if you could figure out a way to market this new drug, OxyContin, to all those patients? The plan would have to remain secret for the time being, but in his memo to the Sacklers, Friedman confirmed that the intention was “to expand the use of OxyContin beyond Cancer patients to chronic non-malignant pain.” This was a hugely audacious scheme. In the 1940s, Arthur Sackler had watched the introduction of Thorazine. It was a “major” tranquilizer that worked wonders on patients who were psychotic. But the way the Sackler family made its first great fortune was with Arthur’s involvement in marketing the “minor” tranquilizers Librium and Valium. Thorazine was perceived as a heavy-duty solution for a heavy-duty problem, but the market for the drug was naturally limited to people suffering from severe enough conditions to warrant a major tranquilizer. The beauty of the minor tranquilizers was that they were for everyone. The reason those drugs were such a success was that they were pills that you could pop to relieve an extraordinary range of common psychological and emotional ailments. Now Arthur’s brothers and his nephew Richard would make the same pivot with a painkiller: they had enjoyed great success with MS Contin, but it was perceived as a heavy-duty drug for cancer. And cancer was a limited market. If you could figure out a way to market OxyContin not just for cancer but for any sort of pain, the profits would be astronomical. It was “imperative,” Friedman told the Sacklers, “that we establish a literature” to support this kind of positioning. They would suggest OxyContin for “the broadest range of use.” Still, they faced one significant hurdle. Oxycodone is roughly twice as potent as morphine, and as a consequence OxyContin would be a much stronger drug than MS Contin. American doctors still tended to take great care in administering strong opioids because of long-established concerns about the addictiveness of these drugs. For years, proponents of MS Contin had argued that in an end-of-life situation, when someone is in a mortal fight with cancer, it was a bit silly to worry about the patient’s getting hooked on morphine. But if Purdue wanted to market a powerful opioid like OxyContin for less acute, more persistent types of pain, one challenge would be the perception, among physicians, that opioids could be very addictive. If OxyContin was going to achieve its full commercial potential, the Sacklers and Purdue would have to undo that perception.
Patrick Radden Keefe (Empire of Pain: The Secret History of the Sackler Dynasty)
To get products approved, firms had to create applications to prove that medicines were "safe and effective”, meaning more effective than doing nothing at all. That standard was never refined to include the more modern question: Is the product more effective than the dozens of other treatments for a particular conditions that are already on the market? Equally important, the FDA yardstick for approval did not include any consideration of price of cost-effectiveness – a metric that virtually all other countries now use as they consider admitting new drugs to their formula.
Elisabeth Rosenthal (An American Sickness: How Healthcare Became Big Business and How You Can Take It Back)
To add to the built-in paradox of the for-profit healthcare system, money made from treating cancer aligns a little too comfortably with the profits made from causing cancer. In the FDA’s first attempt to bring cigarettes under their regulatory purview as a drug (nicotine) delivery device, the Supreme Court in 2000 weighed economic and physical health and, in the final opinion, explicitly noted that the tobacco industry played too important a role in the U.S. economy to be regulated by the FDA—even as it recognized that nicotine was an addictive drug whose dose tobacco companies intentionally manipulated.
S. Lochlann Jain (Malignant: How Cancer Becomes Us)
There were several points to this story. One was how screwed up the incentives were inside the medical-industrial complex. It was possible to spend $1,000,100 on drugs to prevent you from dying without anyone’s having any idea if any of them would work; at the same time, inside of a few weeks but too late to save you, some ill-paid postdoc was able to find a cheap cure. Another was that even when you might have thought that problem was solved, it wasn’t. Two years after Joe and his postdocs published their findings on Balamuthia, the FDA had yet to approve Nitroxoline, long since cleared by European regulators, as a treatment.
Michael Lewis (The Premonition: A Pandemic Story)
In 1993, the FDA granted approval to Monsanto for its genetically engineered recombinant bovine growth hormone (rBGH), brand-named Posilac, for use by the nation’s dairy farmers. It increases milk production by about 10 percent over a cow’s life cycle. It’s the largest-selling cattle pharmaceutical in the United States. But Posilac has always been controversial. More and more cancer specialists are apprehensive, because it may increase the risk for breast, colon, and prostate cancers in humans. Unless the milk you’re drinking is clearly marked “organic” or “rBGH free,” it probably contains this hormone. Incidentally, Posilac is banned in Europe, Canada, Australia, and Japan. This should tell us something.
Vani Hari (The Food Babe Way: Break Free from the Hidden Toxins in Your Food and Lose Weight, Look Years Younger, and Get Healthy in Just 21 Days!)
Calgene's FlavrSavr tomato was the first genetically modified whole food. When Calgene brought it to the FDA in 1992, the tomato was subjected to $2 million-worth of testing by the FDA on top of the testing done by Calgene. In a public meeting the FDA scientists brought the results of their extensive and sophisticated chemical analyses to a panel of external advisers; the panel included representatives of public interest groups and industry, as well as scientists whose specialties ranged from nutrition to basic plant science. The concluding slide of the FDA's presentation had a simple message: Calgene's transgenic tomato … is a tomato. Mendel in the Kitchen: A Scientist's View of Genetically Modified Food
Fedoroff, Nina V.; Brown, Nancy Marie
Ergoloid mesylates (Hydergine) Developed by Albert Hofmann and marketed without FDA approval as a neuroprotective “smart drug,” ergoloid mesylates is reportedly comparable at standard doses to microdoses of LSD. It’s only available on prescription in most Western countries, but you may be able to buy it online elsewhere. 2C-B-FLY Active even at sub-milligram doses, the effects of 2C-B-FLY have been likened to mescaline and MDA (MDMA’s more potent, more psychedelic predecessor). Microdoses of less than 100 μg (0.1 mg) may enhance motivation, empathy, creativity, and philosophical or abstract thinking. 2C-B-FLY is unscheduled in the U.S. but may be considered an illegal analog of 2C-B. In Canada, it’s a Schedule III substance. In any case, it’s widely available online.
Paul Austin (Microdosing Psychedelics: A Practical Guide to Upgrade Your Life)
They were fed around 3,200 calories a day, which was considered a normal amount. (Because it is.) They took jobs on the compound and walked around twenty-two miles a week. Then, for six months, their calories were dramatically cut—in half. They were only served two meals a day, which worked out to roughly 1,600 calories total. The participants were encouraged to keep up their walking. In this experiment, 1,600 calories was considered “semi-starvation,” which is really horrifying when you realize that this is the same “conservative protocol” used by the FDA to “combat obesity.” You’ve probably seen that calorie number floating around fitness magazines and doctor-prescribed diets. These days, 1,200–1,600 calories is considered an acceptable daily amount of calories for men and women.
Caroline Dooner (The F*ck It Diet: Eating Should Be Easy)
Another example is tamoxifen, which is used for treatment of endocrine responsive breast cancer. Tamoxifen is given to patients postsurgery and dramatically reduces the rate of cancer recurrence. This drug is metabolized by cytochrome P450 2D6, the product of the CYP2D6 gene. Based on their DNA, there are patients with little CYP2D6 activity who are poor metabolizers and others with high activity who are extensive metabolizers. An FDA-approved genetic test exists for finding the variants of the CYP2D6 gene to help guide tamoxifen administration, but the lack of study data demonstrating its role in improving patient outcomes has, to date, led insurance companies to refuse to cover the test. Beyond having ramifications for drug efficacy, genetics also may play a role in the side effects of drugs.
Michael Snyder (Genomics and Personalized Medicine: What Everyone Needs to Know®)
We blame the sun for skin cancer, but it’s not that simple. If it were, our years of slathering sunscreen and avoiding the sun would have resulted in a decrease in skin cancer diagnoses. But since sun protection factor (SPF) sunscreens received FDA approval in the 1970s, the incidence of melanoma in children has risen nearly 3 percent per year—throughout the 1970s and 1980s, the incidence of melanoma in the United States increased faster than that of any other cancer. Since the 1960s, rates of skin cancer in lighter-skinned populations—those at highest risk for skin cancer—have continued to increase by between 5 and 8 percent every single year. First-time melanoma diagnoses overall have tripled over the past thirty-five years, and just between 2000 and 2013 there was a nearly 2 percent increase each year.
Liz Wolfe (Eat the Yolks)
Wilson-Donovan had already submitted their application to the FDA in January, months before. Based on the information they were developing now, they were going to ask for Vicotec to be put on the “Fast Track,” pressing ahead with human trials of the drug, and eventually early release, once the FDA saw how safe it was and Wilson-Donovan proved it to them. The “Fast Track” process was used in order to speed the various steps toward approval, in the case of drugs to be used in life-threatening diseases. Once they got approval from the FDA, they were going to start with a group of one hundred people who would sign informed consent agreements, acknowledging the potential dangers of the treatment. They were all so desperately ill, it would be their only hope, and they knew it. The people who signed up for experiments like this were
Danielle Steel (Five Days in Paris)
a. The chocolate in six (6) 100 gram subsamples contains an average of 60 or more insect fragments per 100 grams. or b. Any one subsample contains 90 or more insect fragments, even if the overall average of all the subsamples is less than 60. 2. Rodent Filth a. The chocolate in six (6) 100 gram subsamples contains an average of more than 1.0 rodent hair per 100 grams, regardless of the size of the hairs or hair fragments.
FDA food regulations
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)
Chirality matters. In the curious case of the artificial fragrance limonene, the right-handed form smells like an orange, whereas the left-handed version of this simple ring-shaped molecule smells like a lemon. The smell receptors in your nose are sensitive to chirality, so right- and left-limonene transmit slightly different signals to your brain. Taste buds are less sensitive to the differences between right- and left-handed sugars. They both taste sweet, but our body’s fine-tuned digestive system can process only the right-handed forms. The artificial sweetener tagatose, a zero-calorie left-handed sugar substitute, exploits these properties. The tragic story of thalidomide also rests on handedness. The right-handed version of this drug alleviated morning sickness in pregnant women, but the left-handed variant that inevitably tagged along caused birth defects. Today the FDA imposes strict requirements for chirally pure drugs—regulations
Robert M. Hazen (The Story of Earth: The First 4.5 Billion Years, from Stardust to Living Planet)
ADHD Prescriptions: Diagnosis rates of Attention Deficit Hyperactivity Disorder (ADHD) have skyrocketed 500 percent since 1991, according to the Drug Enforcement Administration. An estimated 7 million schoolchildren are being treated with stimulants for ADHD, including ten percent of all ten-year-old American boys, according to an article published in the Journal of the American Medical Association. A 1998 study by researchers Adrian Angold and E. Jane Costello found that the majority of children and adolescents who receive stimulants for ADHD do not fully meet the criteria for ADHD. The efforts of neurologist Dr. Fred Baughman, ADHD diagnosis critic, led to admissions from the FDA, DEA, Novartis (manufacturers of Ritalin), and top ADHD researchers around the country that “no objective validation of the diagnosis of ADHD exists.” A Maryland Department of Education study found that white, suburban elementary school children are using medication for ADHD at more than twice the rate of African American students.
Mark Sisson (The Primal Blueprint: Reprogram your genes for effortless weight loss, vibrant health, and boundless energy (Primal Blueprint Series))
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)
But I was wrong about that. From the moment of my reluctant entrance into the vaccine debate in 2005, I was astonished to realize that the pervasive web of deep financial entanglements between Pharma and the government health agencies had put regulatory capture on steroids. The CDC, for example, owns 57 vaccine patents1 and spends $4.9 of its $12.0 billion-dollar annual budget (as of 2019) buying and distributing vaccines.2,3 NIH owns hundreds of vaccine patents and often profits from the sale of products it supposedly regulates. High level officials, including Dr. Fauci, receive yearly emoluments of up to $150,000 in royalty payments on products that they help develop and then usher through the approval process.4 The FDA receives 45 percent of its budget from the pharmaceutical industry, through what are euphemistically called “user fees.”5 When I learned that extraordinary fact, the disastrous health of the American people was no longer a mystery; I wondered what the environment would look like if the EPA received 45 percent of its budget from the coal industry!
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
I just have to ask these questions. Are you DEA? FDA? NICB? NHCAA? Are you a private investigator hired by any private or governmental entity? Do you work for a medical insurance company? Are you a drug dealer? Drug addict? Are you a clinician? A med student? Getting pills for an abusive boyfriend or employer? NASA?” “I think I have insomnia. That’s my main issue.” “You’re probably addicted to caffeine, too, am I right?” “I don’t know.” “You better keep drinking it. If you quit now, you’ll just go crazy. Real insomniacs suffer hallucinations and lost time and usually have poor memory. It can make life very confusing. Does that sound like you?” “Sometimes I feel dead,” I told her, “and I hate everybody. Does that count?” “Oh, that counts. That certainly counts. I’m sure I can help you. But I do ask new patients to come in for a fifteen-minute consultation to make sure we’ll make a good fit. Gratis. And I recommend you get into the habit of writing notes to remind yourself of our appointments. I have a twenty-four-hour cancellation policy. You know Post-its? Get yourself some Post-its. I’ll have some agreements for you to sign, some contracts. Now write this down.” Dr. Tuttle told me to come in the next day at nine A.M.
Ottessa Moshfegh (My Year of Rest and Relaxation)
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)
the mystery was far from solved. Nobody understood why heparin—which is made from the mucosal lining of pig intestines, most of which come from China—was suddenly making patients sick. In February 2008, the FDA discovered the likely source of the contamination: a Chinese plant supplying crude heparin to Baxter. In a clerical blunder, the FDA had completely overlooked and failed to inspect the facility, Changzhou SPL, located about 150 miles west of Shanghai. Instead, it inspected and approved a plant with a similar-sounding name. Predictably, once FDA officials finally traveled to Changzhou in February 2008 to make an on-the-ground inspection, they found serious problems. The facility had dirty manufacturing tanks and no reliable method of removing impurities from heparin, and it acquired the crude heparin from workshops that had not been inspected. Chinese regulators were no help at all. A loophole in Chinese regulations allowed certain pharmaceutical plants to register as chemical plants, which made them subject to far less oversight. For U.S. congressional investigator David Nelson, whose committee was now immersed in the heparin crisis as well, the situation laid bare the “classically good reason to be suspect of production coming from any country that doesn’t have competent regulatory authority.” The FDA issued an import alert in March 2008, meaning that Changzhou SPL’s shipments would be stopped at the U.S. border. Though
Katherine Eban (Bottle of Lies: The Inside Story of the Generic Drug Boom)
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)
If you were going to start a bioengineering company, Henry, what would you do? Would you make products to help mankind, to fight illness and disease? Dear me, no. That’s a terrible idea. A very poor use of new technology.” Hammond shook his head sadly. “Yet, you’ll remember,” he said, “the original genetic engineering companies, like Genentech and Cetus, were all started to make pharmaceuticals. New drugs for mankind. Noble, noble purpose. Unfortunately, drugs face all kinds of barriers. FDA testing alone takes five to eight years—if you’re lucky. Even worse, there are forces at work in the marketplace. Suppose you make a miracle drug for cancer or heart disease—as Genentech did. Suppose you now want to charge a thousand dollars or two thousand dollars a dose. You might imagine that is your privilege. After all, you invented the drug, you paid to develop and test it; you should be able to charge whatever you wish. But do you really think that the government will let you do that? No, Henry, they will not. Sick people aren’t going to pay a thousand dollars a dose for needed medication—they won’t be grateful, they’ll be outraged. Blue Cross isn’t going to pay it. They’ll scream highway robbery. So something will happen. Your patent application will be denied. Your permits will be delayed. Something will force you to see reason—and to sell your drug at a lower cost. From a business standpoint, that makes helping mankind a very risky business. Personally, I would never help mankind
Michael Crichton (Jurassic Park (Jurassic Park, #1))
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)
By collecting data from the vast network of doctors across the globe, they added dozens of new compounds to the arsenal—all proven effective against COVID-19. Dr. Kory told me that he was deeply troubled that the extremely successful efforts by scores of front-line doctors to develop repurposed medicines to treat COVID received no support from any government in the entire world—only hostility—much of it orchestrated by Dr. Fauci and the US health agencies. The large universities that rely on hundreds of millions in annual funding from NIH were also antagonistic. “We didn’t have a single academic institution come up with a single protocol,” said Dr. McCullough. “They didn’t even try. Harvard, Johns Hopkins, Duke, you name it. Not a single medical center set up even a tent to try to treat patients and prevent hospitalization and death. There wasn’t an ounce of original research coming out of America available to fight COVID—other than vaccines.” All of these universities are deeply dependent on billions of dollars that they receive from NIH. As we shall see, these institutions live in terror of offending Anthony Fauci, and that fear paralyzed them in the midst of the pandemic. “Dr. Fauci refused to promote any of these interventions,” says Kory. “It’s not just that he made no effort to find effective off-the-shelf cures—he aggressively suppressed them.” Instead of supporting McCullough’s work, NIH and the other federal regulators began actively censoring information on this range of effective remedies. Doctors who attempted merely to open discussion about the potential benefits of early treatments for COVID found themselves heavily and inexplicably censored. Dr. Fauci worked with Facebook’s Mark Zuckerberg and other social media sites to muzzle discussion of any remedies. FDA sent a letter of warning that N-acetyle-L-cysteine (NAC) cannot be lawfully marketed as a dietary supplement, after decades of free access on health food shelves, and suppressed IV vitamin C, which the Chinese were using with extreme effectiveness.
Robert F. Kennedy Jr. (The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health)
Sharon passed around a handout: "Triangle of Self-Actualization" by Abraham Maslow. The levels of human motivation. It resembled the nutrition triangle put out by the FDA, with five horizontal levels of multiple colors. I vaguely remembered it from my one college psychology course in the 1970's. "Very applicable with refugees," Sharon said. "Maslow theorized that one could not move to a higher level until the prior level was satisfied. The first level, the triangle base, is physiological needs. Like food and water. Until a person has enough to eat and drink, that's all one would be concerned with." I'd never experienced not being able to satisfy my thirst or hunger, but it sounded logical that that would be my only concern in such a situation. For the Lost Boys, just getting enough food and water had been a daily struggle. I wondered what kind of impact being stuck at the bottom level for the last fourteen years would have on a person, especially a child and teen. "The second level is safety and security. Home. A sanctuary. A safe place." Like not being shot at or having lions attack you. They hadn't had much of level two, either. Even Kakuma hadn't been safe. A refugee camp couldn't feel like home. "The third level is social. A sense of belonging." Since they'd been together, they must have felt like they belonged, but perhaps not on a larger scale, having been displaced from home and living in someone else's country. "Once a person has food, shelter, family and friends, they can advance to the fourth level, which is ego. Self-esteem." I'd never thought of those things occurring sequentially, but rather simultaneously, as they did in my life. If I understood correctly, working on their self-esteem had not been a large concern to them, if one at all. That was bound to affect them eventually. In what way remained to be seen. They'd been so preoccupied with survival that issues of self-worth might overwhelm them at first. A sure risk for insecurity and depression. The information was fascinating and insightful, although worrisome in terms of Benson, Lino, and Alepho. It also made me wonder about us middle-and upper-class Americans. We seldom worried about food, except for eating too much, and that was not what Maslow had been referring to. Most of us had homes and safety and friends and family. That could mean we were entirely focused on that fourth level: ego. Our efforts to make ourselves seem strong, smart, rich, and beautiful, or young were our own kind of survival skill. Perhaps advancing directly to the fourth level, when the mind was originally engineered for the challenges of basic survival, was why Prozac and Zoloft, both antidepressants, were two of the biggest-selling drugs in America. "The pinnacle of the triangle," Sharon said, "is the fifth level. Self-actualization. A strong and deeply felt belief that as a person one has value in the world. Contentment with who one is rather than what one has. Secure in ones beliefs. Not needing ego boosts from external factors. Having that sense of well-being that does not depend on the approval of others is commonly called happiness." Happiness, hard to define, yet obvious when present. Most of us struggled our entire lives to achieve it, perhaps what had brought some of us to a mentoring class that night.
Judy A. Bernstein (Disturbed in Their Nests: A Journey from Sudan's Dinkaland to San Diego's City Heights)