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"Another kind of clinical research consists of doing drug trials. drug trials have two purposes: to develop new treatments to help patients with a disease, and to prove specific ideas about how a given disease is caused. I gave you one example in the last chapter when I discussed the BioBran trial. A positive outcome would have provided ammunition for the immune dysfunction hypothesis as the cause of CFS. Another example was a trial of an antiviral medication in people with CFS." - Benjamin H. Natelson, M.D., Your Symptoms Are Real: What to Do When Your Doctor Says Nothing Is Wrong (Get the book.)

"Instead of throwing out the bogus trials, negating any pos-sibiHty of Prozac being approved, the accommodating federal agency allowed the tranquilized patients to be counted as if they were legitimate participants in the drug trials. Then, and only then, did the clinical trials demonstrate effectiveness for Prozac—and even that was marginal at best." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.)

"Many of the greatest advances in psychiatry in the last two decades have actually occurred outside the realm of psychotropic medications: in particular, a series of extraordinarily elegant and subtle refinements in social and therapeutic techniques, such as cognitive-behavioral therapy (CBT), that have produced outcomes that would be the envy of many if not most drug trials. For example, CBT has been shown to be as effective or possibly more effective than antidepressants in treating mild and moderate depression, and with a significantly lower recurrence rate." - Charles Barber, Comfortably Numb: How Psychiatry Is Medicating a Nation (Get the book.)

"Steven Nissen is a cardiologist on the staff of the Cleveland Clinic who assumed the role of director of the clinic's contracted drug trials enterprise from Eric Topol after the latter became embroiled in the Vioxx controversy about which we have much to say in later chapters. Nissen and Wolski (2007) undertook a meta-analysis of forty-two treatment trials and concluded that rosiglitazone increased the risk of myocardial infarction. At the end of the paper, Nissen declares receiving research support from no fewer than seven pharmaceutical firms, absent GSK." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.)

"But in Iowa the College of Public Health had become a magnet for industrial drug trials, some of which did not end up serving the public's health. For instance, in 2000 the Bayer Corporation paid the university's public health scientists to make Iowa one of the research sites that recruited patients to take a very high dose of a cholesterol pill called Baycol. The results of that study, published in the spring of 2000, concluded that the 0.8 milligram tablet of Baycol was safe and effective. Just over a year later, federal officials pressed Bayer to take Baycol off the market." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.) "Many of the clinical drug trials published today list four or five academics as authors, while stating in small letters at the bottom of the paper that the research was paid for by the drug company. By hiring the academics as authors and trial investigators, the companies made their studies look more credible and objective. The problem was that behind the scenes, as the clinical trial was performed and the drug was tested on patients, it was often the executives who called the shots." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.) "The drug companies used these private research firms to avoid some of the red tape involved with paying universities to perform the clinical drug trials. "We felt that we needed to get closer to the test tube—to actually work with clinical scientists to develop new drugs," said Thomas L. Harrison, a top executive at Omnicom, when his firm acquired an interest in aCRO called Scirex in 1999." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"It is well documented that belief in a placebo will create the same physiological effects as that of an active agent—so much so that it causes the pharmaceutical industry enormous difficulty when designing drug trials. So many patients receive the same relief and even the same side effects with a placebo as with the drug itself that a placebo is not a true control. Our bodies do not distinguish between a chemical process and the thought of a chemical process." - Lynne McTaggart, The Intention Experiment: Using Your Thoughts to Change Your Life and the World (Get the book.)

"All healing traditions including Western medicine depend at least in part on the power of the placebo, which is an inert, biologically inactive substance used in drug trials to measure the incremental benefit of an active drug. The healing potential of placebos is evident, remarkable even in people with dementia who may not remember they are taking a pill. Many drugs have a tremendously difficult time showing that they have significant benefit over placebos, demanding that we give the placebo effect more clinical and scientific attention." - 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.) "Ultimately, the sample sizes of the study were too small to draw conclusions. In drug trials, the process is divided into four stages. Phase one represents the first efforts to study drug metabolism; phase two is often the first introduction of patients with the illness to the drug; phase three represents larger studies undertaken for actual submission to regulatory bodies; phase four, or the "extension" period, is used to generate further safety data on the drug." - 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.)

"Earlier, I described how double-blind drug trials, in which neither the patient nor the scientist knows who is receiving the real drug and who is taking a placebo, are the most accurate. We did our own double-blind placebo-controlled trial of Enerdyn, an Italian-made product containing proprionyl carnitine (a substance similar to acetylcarnitine). This nutraceutical also contains amounts of a vitaminlike substance called NADH, which was reported to improve CFS symptoms." - Benjamin H. Natelson, M.D., Your Symptoms Are Real: What to Do When Your Doctor Says Nothing Is Wrong (Get the book.)

"CONTROLLED CLINICAL TRIALS PREVENT SUICIDE, REGARDLESS OF THE DRUG THE FDA AND PRO-DRUG ADVISORY committee members at the hearing emphasized that there were no completed suicides in the antidepressant drug trials submitted to it by the drug companies. The FDA also promotes this misleading claim.22 When confronted with the question during a deposition against GlaxoSmithKline in early 2007,1 realized that there were no suicides in either the drug groups or the sugar pill groups." - Peter Breggin, Medication Madness: A Psychiatrist Exposes the Dangers of Mood-Altering Medications (Get the book.)

"It was involved in so many drug trials that it had negotiated standard written contracts with more than a dozen companies to save time. But there were problems. Drug companies were asking for waivers from the university's requirement that the results be published soon after the trial was completed. Without this rule, there was a risk the public would never learn about a study that found a medicine had dangerous side effects or did not work as expected. The university also tried to get the companies to agree to pay the medical bills of any volunteer injured in an experiment." - Melody Petersen, Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs (Get the book.)

"It's worth explaining what this means, since you're liable to see many references, in ads for prescription drugs and in medical journals, to drug trials of this kind. Sick people tend to feel better when receiving treatment of any kind. A century or more ago, medical researchers learned that giving patients even a sugar pill—one that looks identical to the drug being tested but has no real effect— could make some patients feel better. So in order to figure out how effective a new drug is in reducing symptoms, researchers compare its effect against that of a placebo: a sugar pill." - Benjamin H. Natelson, M.D., Your Symptoms Are Real: What to Do When Your Doctor Says Nothing Is Wrong (Get the book.)

"Systematic post-marketing surveillance is called Phase IV drug trials. They are not required. In fact, systematic Phase IV data is seldom pursued unless driven by a product-liability lawsuit. The fda relies on Phase III assurance from the West of Scotland cohort. Over the course of a decade after the study ended, nothing unusual emerged from an analysis of administrative data (mainly hospital records). For all I know, subtle muscle disease, or liver disease, or cognitive impairment is the fate of some." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.) "This issue in uncertainty does not seem to trouble many who design and analyze drug trials, and certainly not many who trumpet the results. That is your first health-related caveat emptor. Is 2 percent a solution? Is it clinically meaningful? Is it meaningful to you? Two percent reduction in nonfatal heart attacks over five years is what we're being offered in the top line of the table as the highly statistically significant finding, likely to occur by chance less than one time in 1,000." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.) "Drazen had been involved in industry-sponsored drug trials prior to accepting the editorship. He claimed that almost all with appropriate expertise to write such articles were disqualified by the former restriction. He even goes on to define "significant financial interest" as excluding mutual funds and the like but not "major research support" and set an "upper limit on the annual sum that a person may receive before a relationship is automatically considered significant," currently at $10,000." - Nortin M. Hadler MD, Worried Sick: A Prescription for Health in an Overtreated America (Get the book.)

"Lipton was chagrined to learn that drug companies are now trying to decipher which kinds of patients respond to sugar pills so they can be eliminated from drug trials! "It inevitably disturbs pharmaceutical manufacturers that in most of their clinical trials, the placebos, the 'fake' drugs, prove to be as effective as their engineered chemical cocktails." In fact he proceeds to point out that the history of medicine is largely the history of the placebo effect, with the use of bloodletting, treating wounds with arsenic and the use of rattlesnake oil." - Susan E. Schenck, The Live Food Factor: The Comprehensive Guide to the Ultimate Diet for Body, Mind, Spirit & Planet (Get the book.)

"One unfortunate reality of drug trials is that the company sponsoring the research usually wants the results yesterday. After all, trials cost money, and pharmaceutical companies want a quick answer to the question: Does the drug work? The results of the modafinil trial show why using a placebo is so important. In our study, a large number of patients were involved at two sites and a smaller number at three other sites, including our own. The sites that had tested the most patients had a huge placebo effect." - Benjamin H. Natelson, M.D., Your Symptoms Are Real: What to Do When Your Doctor Says Nothing Is Wrong (Get the book.)

"Women were not included in drug trials in an effort to protect them and any children if the women became pregnant during the testing. In addition, the hormone fluctuations experienced by women were thought to make them less desirable study subjects than men. In 1993, after researchers discovered that men and women respond differently to drugs, the US Food and Drug Administration (FDA) began requiring that women be included in drug trials for medications that would be taken by them. Among the most popular theories to explain gender-related differences in drugs are... •Hormones." - Bottom Line Health, Bottom Line's Health Breakthroughs 2007 (Get the book.)

"Trick Five: Add a Sedative to the Drug Trial I find it incredible that over half 'of all drug trials submitted to the FDA in seeking approval for the leading SSRI antidepressants allowed a sedative to be given to study subjects. Kirsch and colleagues reported, "In most trials, a chloral hydrate sedative was permitted in doses ranging from 500mg to 2000mg per day. Other psychoactive medication was usually prohibited but still was reported as having been taken in several trials." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"On April 22, 2004 the highly respected British medical journal, The Lancet [6], published an article that was the first meta-analysis done in a peer-reviewed journal of all available drug trials on a specific group of antidepressants. It was conducted by six British academic psychiatrists and researchers who said that, although some published studies made the newer antidepressants (SSRIs) appear effective to doctors, five studies never made public by the pharmaceutical companies who funded them showed that the benefits (if any) did not justify the risks." - Fred A. Baughman, Jr., M.D. and Craig Hovey, The ADHD Fraud: How Psychiatry Makes "Patients" of Normal Children (Get the book.)

"In view of the growing number of users, Mosholder contacted drug manufacturers and requested that they provide additional data from their drug trials. When he completed his study, he was convinced that the British had it right. The drug companies' own data revealed the dangers which most physicians simply did not know existed. He was to present his findings at an FDA advisory committee meeting scheduled for February 2004. However, when his superiors learned of the conclusions he was going to share, they would not allow him to make his presentation." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"Many carry out drug trials for the pharmaceutical giants, for which they receive compensation. When I was in medical school, pharmaceutical reps would take us to lunch at some of the best restaurants, give us leather medical bags, expensive medical textbooks, stethoscopes, and other "toys" to buy our loyalty. They were always friendly, and over time, we did become close friends with them. In private practice, we joked that a drug rep couldn't see us unless he brought some toys." - Russell L. Blaylock, M.D., Health and Nutrition Secrets (Get the book.)

"I have serious questions when I find out that pharmaceutical companies routinely alter scientific data, or hide the results of drug trials they don't like, or bribe doctors to push high-profit drugs onto consumers who largely don't need them. These are questions that any honest observer of this industry would ask, but almost no one is asking today. FDA bureaucrats have sold their souls (and their loyalty) to the drug companies, as you will see in chapter 2." - Mike Adams, Natural Health Solutions (Get the book.) "Routine scientific fraud in both the design and the selective reporting of so-called "clinical drug trials," which are frequently rigged to produce a positive outcome while minimizing safety risks. •* Routine bribery of physicians through consulting fees, Continuing Medical Education vacations to exotic destinations, and kickback programs that reward doctors for writing brand-name prescriptions to patients under the guise of signing them up for clinical trials." - Mike Adams, Natural Health Solutions (Get the book.)

"In the real world, once a drug is released, it is taken by many people with various health problems, typically taken at higher doses, and often taken for years or even for life, not the 6 to 8 weeks common to initial drug trials. Put it all together, and it becomes apparent why new drugs should always be considered riskier than drugs that have been on the market for many years. The research on how long it takes for new drugs to begin causing serious health problems is another reason to view drugs with great caution." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.) "It was also reported that though for-profit drug companies fund over 80% of all drug trials, only 13% of all listed trials were submitted by for-profit companies.31 Most of those willing to obey the law were government agencies and non-profits. This situation will not last forever.32 But, until compliance with the law becomes the norm, how are we to know about adverse drug effects that may not develop for years after drug exposure? We may not have any clear indication of how many antidepressant users will develop movement disorders for years." - Dr. Timothy Scott, America Fooled: The Truth About Antidepressants, Antipsychotics and How We've Been Deceived (Get the book.)

"Most people didn't know that doctors routinely accept bribes (including hundreds of thousands of dollars in "contractor's fees" for signing patients up for drug trials), so this news may come as a bit of a shock to some. The majority of doctors say these gifts don't influence their prescribing behavior, just like the majority of consumers claim television advertising has no influence on their grocery purchases, either. Studies prove otherwise. Studies prove that drug company gifts to doctors are, indeed, not only effective, but quite a bargain for the drug companies." - Mike Adams, Natural Health Solutions (Get the book.)

"The group elected to utilize "Expert Consensus Guidelines," rather than clinical studies or drug trials to form these recommendations. 2. Essentially, TMAP opted to "establish" new drugs as the best drugs for various illnesses by surveying the opinions of doctors and psychiatrists of TMAP's own choosing. No hard science, no patients, no study review, and no clinical trials—just the "Expert Opinions" of persons TMAP elected to survey. 3. TMAP formulated the questions to be posed to these physicians and formulated the structure of the responses permitted." - Kelly Patricia O'Meara, Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills That Kill (Get the book.)

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