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Quotes about Drug Approval from the world's top natural health / natural living authors

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"Major responsibility falls on the shoulders of our national and international regulatory bodies: They have the task of setting the standards required for drug approval and monitoring the behavior of the pharmaceutical industry. Regulators must limit the priority given to minimally effective drugs such as cholinesterase inhibitors, and priority should be given to new chemical entities. The pharmaceutical industry can play a vital role in the future of brain aging, but it must accept its mantle of responsibility and work as an agent of world benefit." - Peter J. Whitehouse and Daniel George, The Myth of Alzheimer's: What You Aren't Being Told About Today's Most Dreaded Diagnosis (Get the book.)

"Janet Woodcock, who was director of FDA's Center for Drug Evaluation and Research, has stated that tight deadlines for drug approval were creating "a sweatshop mentality" within the agency.32 The mechanism for speeding things up is very simple: the drug companies pay the FDA directly to evaluate and approve their drugs, to the tune of millions of dollars. Under the terms of the current PDUFA, Big Pharma paid the FDA $305 million in 2007 to review their drugs on an expedited basis. Under the proposed PDUFA IV, the annual user fees will be increased to about $393 million." - Charles Barber, Comfortably Numb: How Psychiatry Is Medicating a Nation (Get the book.)

"At that time it could take up to two years to gain drug approval, two years too long if you were suffering from HIV-AIDS. Throughout the 1980s, AIDS activists and patients echoed the drug companies' sentiments, complaining that it was taking too long to bring disease-fighting drugs to market. The pharmaceutical industry lent a sympathetic ear and a loud voice to calls for speeding up the approval of AIDS drugs such as Agenerase (amprenavir). Since drugs are on patent for a limited number of years, every year spent waiting for approval from the FDA means losing a year of profits." - J. Douglas Bremner, Before You Take that Pill: Why the Drug Industry May Be Bad for Your Health (Get the book.)

"What most consumers don't understand is that drug testing is often very limited before drug approval. New drugs are tested on a few hundred to a few thousand people often for a very limited time (usually a few weeks to a few months).Then they are released on the market, supported by more than $30 billion in pharmaceutical advertising dollars (or about $25,000 a year for each one of the 737,000 physicians in America). Once approved, these drugs can be prescribed for any use. We in the medical industry call these "off-label uses." - Mark Hyman MD, The UltraMind Solution: Fix Your Broken Brain by Healing Your Body First (Get the book.)

"Most professional publications about drugs, especially in the initial years after drug approval, draw extensively from the label. Overall, the drug label or "package insert" is the single most important document in communicating the therapeutic and adverse effects of the drug to both professionals and consumers. When the FDA makes a significant change in a label, such as requiring a black-box warning for antidepressant-induced suicidality, it is big news in both professional publications and the public media." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.) "I studied federal regulations governing the FDA, and took intensive seminars intended for drug company officials concerning the operations of the FDA and the procedures for obtaining drug approval. I located and then reviewed hundreds of published studies concerning Prozac, especially how it causes adverse effects. At the same time, I reviewed innumerable large storage boxes of sealed Eli Lilly memos, letters, and studies concerning the development and marketing of Prozac, some obtained on my own through FOIA and some obtained from the drug company by the consortium of lawyers." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.)

"While 1300 people were being added to the division of the FDA that approves new drugs (to decrease new drug approval time), 1000 were being taken off other FDA surveillance duties, including inspection of drug manufacturing sites. And the real truth about counterfeit drugs from Canada? Jirina Vlk, spokesperson for Health Canada, the equivalent of the FDA, told me on January 28, 2004, that she was not aware of any counterfeit drug's ever having been sent from a registered Canadian pharmacy or pharmacist to the United States." - John Abramson, Overdosed America: The Broken Promise of American Medicine (P.S.) (Get the book.) "Because crucial recommendations about drug approval and drug labeling are made at the FDA's Advisory Committee meetings, federal law "generally prohibits" the participation of experts who have financial ties to the products being presented on these committees. An article in USA Today in September 2000 shows, however, that the FDA granted so many waivers?00 between 1998 and 2000—that 54 percent of the experts on these all-important Advisory Committees had "a direct financial interest in the drug or topic they are asked to evaluate." - John Abramson, Overdosed America: The Broken Promise of American Medicine (P.S.) (Get the book.) "Janet Woodcock, director of CDER since 1994, wrote that tight deadlines for drug approval were creating "a sweatshop environment that's causing high staffing turnover." The most dangerous consequence of these changes was that the number of drugs approved by the FDA but later withdrawn from the market for safety reasons increased from 1.6 percent of drugs approved between 1993 and 1996 to 5.3 percent between 1997 and 2000. Seven drugs that had been approved by the FDA after 1993 were withdrawn from the market because of serious health risks." - John Abramson, Overdosed America: The Broken Promise of American Medicine (P.S.) (Get the book.) "Pfizer had a new "HDL-elevator" drug that was well along in the pipeline of drug approval, and already being tested in clinical trials. It was also becoming clear that senior citizens would soon get some kind of assistance with prescription drug coverage from the federal government. Lower-income minority communities like Harlem represent relatively unpenetrated markets for expensive drugs with purported widespread benefits. A generous prescription drug benefit would make statin drugs affordable to many residents in this community who could not previously afford them." - John Abramson, Overdosed America: The Broken Promise of American Medicine (P.S.) (Get the book.)

"Many FDA whistleblowers have explained that within the agency political managers (those appointed by the Commissioner to head the agency centers and their underlings) have threatened them with retaliation for submitting intra-agency safety reports recom- mending against drug approval, or in favor of label warnings. Many have explained that they have been punished for testifying before Congress concerning FDA approval of unsafe drugs." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "The cost to bring a new drug to market exceeds $860 million, thus forming an insurmountable barrier to entry—making drug approval illusory for all but the wealthiest institutions in the world. The enforcement authorities at FDA, through district offices across the country, spend much of their time policing the market to protect FDA approved drugs from competition.181 They endeavor to find instances where drugs shipped for export or made by FDA approved drug manufacturers overseas and sold there at significantly lower prices are reimported into the United States." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "By statutory design, the new drug approval process prevents any company from marketing a drug unless that company has obtained FDA approval.180 Unlike the system for over-the-counter drugs, in the case of prescription drugs first approved by FDA and still under patent protection, no other party is permitted to produce a competing compound and market it without submitting and prose- cuting to FDA approval a new drug application." - Jonathan W. Emord, The Rise of Tyranny (Get the book.) "In the case of the drug industry, the FDA has ceded so much control over the drug approval process to the industry that FDA regularly approves drugs that its own medical reviewers have defined as unsafe and as likely to cause significant loss of life or permanent disability. Thus, Vioxx entered the market and killed some 55,000 Americans (comparable to the number that were killed in the Vietnam war); Ketek, Serevent, Rezulin, Redux, and a dozen others have entered the market causing scores to die and many more to suffer serious debilitating injuries." - Jonathan W. Emord, The Rise of Tyranny (Get the book.)

"When you hear drug companies complain about the high cost of drug approval, don't believe it. They love it. That's what keeps small players from disrupting their multi-billion dollar profit factory. 2Actually, this is probably the biggest single factor. In the end, ego is more important than money. • Even though the concept of a "cure for cancer" is basically bogus (more on that later), you will still be asked to raise and contribute billions of dollars to search for it.1 So Let's Talk About the Nature of the Disease." - Jon Barron, Lessons from The Miracle Doctors: A Step-by-Step Guide to Optimum Health and Relief from Catastrophic Illness (Get the book.)

"When allowed to conduct their own clinical trials, (as they are now doing), the companies employ every trick in the book to assure they will receive the drug approval they are looking for, which was reflected in the above report. The studies are seldom of sufficient duration necessary to identify any long-term risks." - Dr David W Tanton, Ph.D., Antidepressants, Antipsychotics, And Stimulants - Dangerous Drugs on Trial (Get the book.)

"He ignored that risk and instead had the courage to come forward in the public interest to try to effect positive change in the drug approval process. If you would like to read this damning testimony for yourself, visit the Fit Advocate Web site at www.FitAdvocate.com where you will find a link that will enable you to review it in its entirety. If I have not yet effectively conveyed the risks involved with prescription drugs and the FDA approval process, this document will. One Person's Tonic, Another One's Toxin Each human being is different." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"The HRSD was the primary measure of depression in the NIMH STAR*D study, and it is routinely used in antidepressant studies evaluated by the FDA for drug approval. However, even the American Journal of Psychiatry, the American Psychiatric Association's own journal, concluded in 2004, "Evidence suggests that the Hamilton depression scale is psychometrically and conceptually flawed." And the Journal of Clinical Psycho-pharmacology noted in 2005, "When looking closely at the construction and content of the HRSD, it is clear that this is a flawed measure." - Bruce E. Levine, Surviving America's Depression Epidemic: How to Find Morale, Energy, and Community in a World Gone Crazy (Get the book.)

"To begin with, the FDA allows researchers connected to pharmaceutical companies, who have a financial stake in the outcome, to be members of drug approval advisory panels (often making up 50% of the members). [5] And the evidence these panels are reviewing? It comes from studies conducted by the drug companies themselves, where positive results are reported an unsurprising 98% of the time. Are the drugs really this good? Of course not, but their creators are very good at suppressing negative outcomes and massaging positive outcomes." - Fred A. Baughman, Jr., M.D. and Craig Hovey, The ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children (Get the book.)

"But it is not just the drug approval process which was at fault. Poorly designed studies which fool not just the public but also the researcher responsible for the study are published daily. This happened hundreds and hundreds of times with the HRT research. And of course, the books, journal articles, continuing education conferences, literature provided by drug representatives and advertising all led the American public and physicians to assume HRT was the best medical practice. We were all fooled. Today we are being fooled about mind drugs." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.) "In Chapter 9, The FDA drug approval Process, I will note that when Merck was ready to do a large trial with Vioxx, they gave patients only half the dosage used in an earlier trial—a trial which had resulted in a large number of heart attacks and strokes.12 Trick Three: Use a "Placebo Washout" When comparing a new drug to a placebo, researchers face a dilemma. A large number of those given a sugar pill respond very favorably to the pill." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.) "To assume, as many do, that once a drug has received FDA approval it can be considered safe reveals a fundamental ignorance of the drug approval process and the dangers of drugs. It can take years before a "safe" drug is found to damage the heart, kidneys or liver or cause other unanticipated harm." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.) "Typically I learn these facts after one of my lectures on depression, mind drugs or the drug approval process. The students who approach me often express anger that their physician would put them on Zoloft, Paxil or another mind drug in view of the research. I want you to know what I routinely say to these students. The following dialogue is reflective of those conversations and includes my standard response. My response: I don't think you should get angry at your physician. She is probably very conscientious and works very hard to provide you good medical care." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"Richards goes on to say, "The Bush-appointed new FDA leadership is intent on removing any brakes being applied to the drug approval process, quite happy to turn ill Americans into human guinea pigs." A recent example of how the seeds of conflict take root for personal benefit is the former FDA Commissioner Lester M. Crawford, who recently pleaded guilty to lying about his substantial stock ownership in companies he was supposed to regulate. With the foxes guarding the henhouse, how safe do you think we are? The rules of the FDA are in opposition to consumer protection." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"While the drug approval system was changing, the drug distribution system — the manner in which people got drugs — was not. Compared to the full-on spigot at the FDA, the pipeline to the patient was a bottleneck: every drug dispensed and paid for at the pharmacy was the end result of a long and slow process of convincing individual physicians to take a chance on a new treatment. Worse, the bottleneck was thin. Eighty percent of all prescriptions in the United States were issued via a mere 400,000 physicians." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"This brings us to the drug approval process. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation.5 The key words in this description of the agency's mission are "protecting the public" and "assuring safety." After celebrating 100 years of service to our country, the FDA cannot predict the long-term effect of any drug, nor can the agency guarantee the safety of the drugs they approve." - Craig Pepin-Donat, The Big Fat Health and Fitness Lie (Get the book.)

"They could also have a voice in the drug approval process," mainly through testifying at scientific advisory meetings, which often give the key thumbs-up or -down on a new drug. Mossinghoff encouraged the trend. He realized that such testimony would be effective and forthcoming at the right time — when any given NDA was in trouble — if and only if he built strong relations with patient groups early in the approval process. If he didn't, he would leave himself open to the charge of opportunism." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.) "Gilbert McMahon, the Commission on the Federal drug approval Process was originally created as an evenhanded, fact-finding mission to discern whether many of the industry's complaints about the FDA were justified. Undei Reagan, it essentially became an industry organ, funded not by the government but — under the guise of budgetary efficiency — by private interests and philanthropists in tune with the president's deregu-latory impulses." - Greg Critser, Generation Rx: How Prescription Drugs are Altering American Lives, Minds, and Bodies (Get the book.)

"We welcome constructive criticism from well-informed scientists and interested consumers, and we pledge to our public that no new animal drug approval will be undertaken casually and without adequate data. Sincerely yours, Gerald Guest, DVM Center for Veterinary Medicine, FDA Author's Rebuttal of FDA Response August 25, 1989 Dear Dr." - Samuel S. Epstein, M.D., What's In Your Milk?: An Exposé of Industry and Government Cover-Up on the Dangers of the Genetically Engineered (rBGH) Milk You're Drinking (Get the book.) "We welcome constructive criticism from well-informed scientists and interested consumers, and we pledge to our public that no new animal drug approval will be undertaken casually. Gerald B." - Samuel S. Epstein, M.D., What's In Your Milk?: An Exposé of Industry and Government Cover-Up on the Dangers of the Genetically Engineered (rBGH) Milk You're Drinking (Get the book.)

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