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The sad truth of the matter is that Americans are now spending more money on anti-depressant medication than 2/3 of the countries of the entire world spend on their GNP. (see Murphree R, "The Depressing Truth About Antidepressants," The American Chiropractor, Vol. 29 (4), April, 2007) Consider the following; in 1988 the Food and Drug Administration approved and cleared the way for the then brand new anti-depressant drug called Prozac. By 1990, Prozac was the #1 anti-depressant drug in America. It was known then as the latest wonder drug. By 1994, it had become the fastest selling drug in the history of America pharmaceuticals. By 2000, one in ten American women took an anti-depressant such as Prozac, Paxil or Zoloft thus tripling the use of pharmaceuticals by American adults. Other drugs Americans injest with nearly as much gusto include cholesterol lowering meds, asthma control and weight control. Health care costs in 2002 had reached $1.62 TRILLION of which prescription meds accounted for a staggering $160 billion. The health bill for America in 2007 was at $2 Trillion and it can logically be assumed that pharmaceuticals account for about $200 billion of that. (Vedantam S, "Antidepressant Use By US Adults Soars," Washington Post, Dec. 3, 2004)
As a group, Zoloft, Prozac, Paxil, Celexa are known also as SSRI drugs-selective serotonin re-uptake inhibiting drugs. Serotonin is a well known and omnipresnet neuro-transmitter found primarily in the brain. By keeping serotonin present at neural sites, the re-uptake inhibitors keep the brain neurons firing and the idea is that people won't be as depressed. Anti-depressant costs, by 2003 , had reached $37 Billion. Interestingly, the FDA approved Eli Lilly's Prozac based on just three studies involving 286 patients over a period of six weeks. Of the 14 studies submitted for review, only the three "proved" that Prozac was more effective that a placebo! Not surprisingly, about half of the known studies show that up to 70% of patients taking SSRI meds do just as well by taking a placebo or sugar pills.
Boston Spine Clinicsis dedicated to wholistic living.
Hiding Test Results:
BOSTON (1/17/08)- Nearly a third of antidepressant drug studies are never published in the medical literature and nearly all happen to show that the drug being tested did not work, researchers reported on Wednesday. And in some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University. Even if not deliberate, this can be bad news for patients, they wrote in their report, published in the New England Journal of Medicine.
"Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients and, thus, the public health," they wrote.
The idea that unfavorable test results get quietly tucked away so nobody will see them -- sometimes call the "file drawer effect" - has been around for years. The Turner team was able to study the question because the U.S. Food and Drug Administration has a registry in which companies are supposed to log details of their drug tests before the experiments are begun. They could see which experiments approved by the FDA between 1987 and 2004 were ultimately publicized in the medical literature and the main criteria the researchers planned to measure success.
"It tells you where they placed their bets before they saw the data," Turner said in a telephone interview.
Of the 74 studies that started for the 12 antidepressants, 38 produced positive results for the drug. All but one of those studies were published. However, when it came to the 36 studies with negative or questionable results, as assessed by the FDA, only three were published and another 11 were turned around and written as if the drug had worked.
"Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome," said the team.
For example, of the seven negative studies done on GlaxoSmithKline's Paxil, five were never published. The researchers found three studies for GSK's Wellbutrin SR, but the two negative ones never reached print. There were five studies for Pfizer's Zoloft, but the three showing the drug to be ineffective were not published and a fourth study, ruled as questionable by the FDA, was written and published to make it appear that the drug worked. A Glaxo spokeswoman said the company posts the data from all of its trials, positive or negative, on the Internet.
"GlaxoSmithKline agrees that public disclosure of clinical trial results for marketed medicines is essential and fully supports registration of all trials in progress," she said.
Pfizer was not immediately available to comment.
Turner and his colleagues did not find out who was to blame for not publishing the studies. Although the authors and drug company sponsors may not have submitted the unfavorable results for publication, medical journals and their editors may have played a role by deciding they would rather publish favorable results.
"There's an expectation that if you get a positive result, that's what you're supposed to do, and if you get a negative result you have failed," said Turner. "The first impulse is to say, 'I was wrong. Maybe I should move on to something more interesting"' so the results may never get written up.
What About KIDS??
Oddly, or maybe to some, not surprisingly, the fastest growing market niche for sales of anti-depressant drugs has been with preschool children, ages two to four. By 2003, more than one million American children were on legally prescibed anti-depressant medications. This should be worrisome to all concerned considering the fact that even the FDA, who approved these drugs in the first place, has repeatedly warned of the increased risk of suicide in kids under the age of 18. Adding to this twisted scenario is the fact that many of the SSRI medications have proven to be utterly useless in the so-called "treatment" of adolescent depression. Courtroom documents made available reveal a telling internal E mail memoranda from pharmaceutical giant GlaxoSmithKline, "Essentially, the study (concerning Paxil) did not really show it was effective in treating adolescent depression, which is not something we want to publicize." Other SRRI drugs have been found to be just as dangerous. Zoloft has been linked to suicidal issues. Pediatric studies involving Zoloft show it to be no more than 10% more effective than placebos. To boot, the side effects suffered through the use of Zoloft are legion, approximately 300 TIMES more than taking a mere placebo. (Murphree ibid.)
December 2006-Side Effects: The FDA gave a national warning; that anti-depressants-ALL OF THEM- cause increased suicide rates in young adults. Records show that suicide deaths occur over twice the amount in people under 25 years old with the use of anti-depressants as oposed to population controls that don't utilize anti-depressants. Even more damning is that pharmaceutical giant Eli Lilly KNEW ALL ALONG about this grim side effect! From their earliest trials for Prozac, internal studies revealed that Prozac increased the risk of suicide by as much as 12 to 1 over placebos or older generations of anti-depressants. Be advised: people older than 25 are not immune from increased suicidal risks when taking SSRI drugs. Common side effects of these drugs include: anxiety, depression, headaches, chest and general muscle pain, weakness, sleeplessness, drowsiness, alterations in sex drive, dry mouth, stomach irritation, loss of appetite, dizziness, nausea, rash, intense itching, weight gain, diarrhea, impotence, hair loss, dry skin, bronchitis, abnormal heart rate, twitching, anemia , low blood sugar and thyroid alternations. Prozac alone has been directly linked to over 1,734 suicides to say nothing of the 28,000 adverse reactions documents in patients. Add to this, the FDA estimates that only 1%-5% of all negative drug reactions are ever reported. If one believes that thesis, then the suicide rate jumps to 156,000+ and over 2 million adverse reactions area probably occuring nationally each year.
It is estimated that 3 percent of children and about 12 percent of teens suffer from depression. The increased awareness of childhood depression and its impact on a child has led to an increase in the use of antidepressants to treat these children. However, since Prozac is the only antidepressant approved to treat Pediatric depression, many other drugs are used off-label. Although off-label prescribing is a common, and usually safe, practice when there aren't other treatment options, recent reports of a possible link to an increased risk of suicide for kids taking antidepressants has led some experts to question whether they should be used at all. These concerns recently led the FDA to warn that children should not be prescribed Paxil, which is commonly used to treat adults with ADHD.
PDUFA: Making this story even more incredible was the passage by Congress in 1992 of the Prescription Drug User Fee Act (PDUFA) which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process. Sounds official doesn't it? The end result of this act was a public disaster for consumers but a financial boom for the pharmaceutical industry. More drugs could literally been rushed to market this way and the money still hasn't stopped rolling in. Adding insult to injury, most of the Board sitting at the FDA for drug oversight are psychiatrists with financial ties to pharmaceutical companies.
Chemical Imbalance: The crux of nearly all of psychiatry is the belief in fabled "chemical imbalances" in the brain. Deductive yes, proven no. To date, there is NO TEST that determines Chemical Imbalances in human beings. Thus, the plethora of drugs that are handed out like so much candy in this country is based on sheer opinion. Which leads us to our next sub-topic:
DSM: The Diagnostic and Statistical Manual of Mental Disorders (DSM) is published by the American Psychiatric Association and provides a common language and standard criteria for the classification of mental disorders. It is used in the United States of America and in varying degrees around the world, by clinicians, researchers, psychiatric drug regulation agencies, health insurance companies, pharmaceutical companies, and policy makers. There have been five revisions since it was first published in 1952, gradually including more mental disorders, although some have been removed and are no longer considered to be mental disorders, most notably homosexuality. The manual evolved from systems for collecting census and psychiatric hospital statistics, and from a manual developed by the US Army, and was dramatically revised in 1980. The last major revision was the fourth edition ("DSM-IV"), published in 1994. There is currently a 5th Edition being edited. Be advised: this huge book started out as a consensus document and remains so to this day. A consensus document: there were never any double blind tests being performed, no scientific method. It remains a big book (originally 130 pages with 106 disorders) consisting of 866 pages with thousands of mental conditions listed complete with CPT coding. In short, it is the guide book on getting paid. In 1966 there were 44 psychotropic drugs. There are now 174.
MORE Side Effects and Long Term Issues? We should revisit the side effects again. These are generally relevant to adults who injest SSRI drugs: again, we see generalized muscle spasms/aches/pains. Usually, these spasms are noted in the neck, low back and shoulders. A big issue with adults taking SSRI drugs is sleep deprivation. Sleep disturbances that may manifest either as insomnia or somnolence (sleep walking), have been noted in over 25% of patients taking SSRIs. A typical medical scenario in this case follows one drug after another to counteract the previous drug's side effects. This "merry-go-round" obviously never ends since all drugs have side effects. Thus, a patient who can't sleep gets a script for a common tranquilizer called Ambien. The patient's sleep gets better but the side effects from Ambien cause short term memory loss, flu-like symptoms, general "brain-fog," early morning fatigue and depression. This is not a problem for there are a host of drugs to counteract all of those symptoms. Aderrall is thus scripted to wake the patient up in the morning. It doesn't do anything for the other symptoms. But wait, the Aderrall itself is now causing anxiety and panic. Not to worry, this patient's MD scripts Xanax. This counteracts the anxiety. Of course Xanax itself causes a host of side effects, most of which resemble what the SSRI drugs were causing in the first place in addition to blurred vision, headache, seizures, slurred speech, difficulty in depth perception. And on and on it goes with the medical prescription game.
As we stated earlier, SSRI drugs work by blocking the removal of a vital brain neurotransmitter called Serotonin. The idea is that by keeping Serotonin awash in the brain, patients won't become distracted, distant, depressed, psychotic and so forth. The problem is that over time, the brain tries to overcompensate for this by shutting down production of the neurotransmitter. As time goes by, the brain automatically seeks to reduce the number of serotonin receptors. This becomes a cascade effect such that many Serotonin receptors disappear permanently. It is for this reason that many patients switch medications because they think the SSRI drug they are currently on isn't working any longer. The reality is that the drug itself probably isn't performing as advertised anyway together with the fact that the brain is permanently turning off Serotonin uptake sites. It is a viscious cycle that many patients cannot recover from. It is also very dangerous to patients; it leaves them dependent of a "medication" that is slowly causing the brain to alter it's own anatomy and physiology in response to the drug.
Help Is On The Way; Natural Methods May Really Help With Depression:
Dr. Murphree tells us that there is an alternative to the drug culture: He says that the use of amino acids when combined with essential vitamins and minerals are really the basic incredients of neurotransmitters. With that in mind, we understand that the amino acid tryptophan actually turns into Serotonin. Also known as 5-hydroxytryptophan, "tryptophan" /5HTP is as good, if not better, than the scripted drugs this country is swimming in. He also reminds us that there are over 100 peer-reviewed studies showing that S-adenosyl-methionine (SAMe) is a safe and effetive anti-depressant. SAMe apparently increases the action of several neurotransmitters including Serotonin, Norephinephrine and Dopamine. Another review of 23 randomized, double-blinded, placebo controlled studies involving a sizeable subject group of over 1700 people with mild to moderate depression revealed that the herb "St. John's Wort" was nearly THREE TIMES SUPERIOR to placebos in relieving depressive symptoms.
I look forward to the day when the majority of people in need of this kind of therapy turn to a more wholistic approach to their issues rather than automatically succumbing to the drug mentality.
"Prozac Backlash : Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives "
by Joseph Glenmullen
Editorial Book Review by Amazon.com
It seems like it was just yesterday that Prozac was a miracle pill, a medication that could not only make sick people well, but "better than well." By the end of the 1990s, Prozac and similar drugs -- Paxil, Zoloft, and others -- were being prescribed for everything from depression to anxiety to drug addiction to ADD. About 70 percent of prescriptions for these antidepressants were being written by family physicians, rather than psychiatrists.
Dr. Joseph Glenmullen, a psychiatrist who has a private practice and also works for Harvard University Health Services, sees this antidepressant mania as dangerous, even reckless. He notes that these drugs can have severe side effects, including uncontrollable facial and body tics, which could be signs of severe and permanent brain damage. About 50 percent of patients suffer often-debilitating withdrawal symptoms from them, and about 60 percent end up with sexual dysfunction. And Prozac may make a small number of people homicidal or suicidal, or both.
But there are alternatives: in Germany, for example, St. John's Wort (seen at right) outsells Prozac 25 to 1, showing that doctors and patients there understand that the herbal remedy works as well as the synthetic ones for mild to moderate depression. [Editor's note: St. John's Wort has been shown to interfere with the actions of the transplant rejection drug cyclosporin and the AIDS drug indinivir.] And diet, exercise, 12-step programs, and good old-fashioned psychotherapy can work well, too. Even for severe depression requiring medication, Dr. Glenmullen shows how the drugs can be used with other treatments and then discontinued after a year or less. St. John's WORT seen above
Moreover, Prozac Backlash discusses exactly what depression is and isn't; Dr. Glenmullen reviews hundreds of scientific studies, and discusses numerous case studies from his practice and others. Because of that detail, medical professionals may be this book's most likely readers, but anyone who has been on an antidepressant, or is close to someone who is, will also want to give Prozac Backlash a careful read. The brain you save could be your own. -- Lou Schuler
Roughly 28 million Americans -- one in every ten -- have taken Prozac, Zoloft, or Paxil or a similar antidepressant, yet very few patients are aware of the dangers of these drugs, nor are they aware that better, safer alternatives exist. Now Harvard Medical School's Dr. Joseph Glenmullen documents the ominous long-term side effects associated with these and other serotonin-boosting medications.
More Side Effects: These side effects include neurological disorders, such as disfiguring facial and whole-body tics that can indicate brain damage; sexual dysfunction in up to 60 percent of users; debilitating withdrawal symptoms, including visual hallucinations, electric shock-like sensations in the brain, dizziness, nausea, and anxiety; and a decrease of antidepressant effectiveness in about 35 percent of long-term users. In addition, Dr. Glenmullen's research and riveting case studies shed shocking new light on the direct link between these drugs and suicide and violence.
Prozac Backlash provides authoritative, balanced information on the efficacy of these drugs, explaining how they react chemically in the body, when they should and should not be prescribed, and what risks they present. Equally important, the book informs readers of the many safe, effective alternatives to using such drugs -- alternatives that can restore your spirits, keep your weight down, and make your sex life as vital as ever.
Dr. Glenmullen argues that antidepressant drug therapy is justified only in moderate to severe cases -- no more than 25 percent of patients currently taking these drugs -- and that we should avoid patients' exposure to these drugs whenever possible. The dangerous side effects, he points out, are caused by Prozac backlash, which is the brain's reaction to artificially elevated levels of serotonin.
Using vivid real-life stories from his work at Harvard, his private practice, and the latest medical research, Dr. Glenmullen explains the real role of serotonin in depression and challenges the popular, hypothetical notion of a "serotonin deficiency" allegedly corrected by the drugs. He relates the research history of Prozac and similar drugs, and includes disturbing facts about the influence of drug companies and HMOs on media representation of that research.
Prozac Backlash offers new hope to millions with effective alternative treatments, including psychotherapy, cognitive-behavioral treatment, herbal remedies like St. John's Wort, family therapy, and twelve-step programs. Dr. Glenmullen shows how these alternatives work not only for depression but for a wide range of problems, such as anxiety, phobias, obsessions, compulsions, sexual addictions, drug and alcohol abuse, and eating disorders. He also provides countless examples of the successful application of these treatments where drug exposure has been reduced or eliminated altogether.
Written by a doctor with impeccable credentials, Prozac Backlash is filled with compelling, sometimes heartrending stories and is thoroughly documented with extensive scientific sources. It is both provocative and hopeful, a sound, reliable guide to the safe treatment of depression and other psychiatric problems.
Although not an Anti-Depressant, Oxycontin is frequently used and abused by people taking Anti-Depressants. Check out this timely headlined article:
"Drug maker admits misleading public."
>Purdue Pharma and three executives will pay $634.5 million over OxyContin claims.
By Martin Zimmerman, Times Staff Writer
May 11, 2007
The maker of the painkiller OxyContin and three of the company's top current and former executives will pay $634.5 million in fines after pleading guilty Thursday to charges that they misled the public about the drug. A Justice Department spokeswoman said it was one of the largest financial penalties ever assessed against a drug maker. Stamford, Conn.-based Purdue Pharma was accused of making claims that OxyContin was less addictive and less subject to abuse than other pain medications and continued to do so despite warnings to the contrary from doctors, the media and members of its own sales force.
"In the process, scores died as a result of OxyContin abuse and an even greater number became addicted to OxyContin," U.S. Atty. John Brownlee of the Western District of Virginia, whose office brought the case, said in a statement.
The charges stemmed from sales practices used from 1996 to mid-2001. It was the latest black eye for OxyContin, a drug that has been linked to hundreds of overdose deaths and is a favorite of drugstore thieves and illicit online drug buyers. Called by such street names as hillbilly heroin and oxy, the drug has been linked to celebrities including conservative radio commentator Rush Limbaugh and singer/actress Courtney Love.
Perdue Pharma pleaded guilty to one felony count of fraudulently misbranding a drug. Chief Executive Michael Friedman, general counsel Howard Udell and former Chief Scientific Officer Paul D. Goldenheim each pleaded guilty to one misdemeanor count of misbranding a pharmaceutical. Under the agreement, Perdue Pharma will pay $600 million in penalties, including $160 million to reimburse state and federal healthcare programs and $130 million to resolve private lawsuits that are pending. The three executives will pay $34.5 million in fines to Virginia.
Perdue Pharma, which sold $1.3 billion worth of OxyContin in 2004, accepted responsibility for its actions and said it had taken steps to prevent a recurrence of the problems. The guilty pleas came two days after the company agreed to pay $19.5 million to 26 states, including California, to settle complaints that it encouraged doctors to over-prescribe the drug. OxyContin is a trade name for oxycodone, a powerful opiate also marketed under such brand names as Percocet and Percodan. It is prescribed as a time-release pill designed to be swallowed whole and digested over a 12-hour period. Oxycodone is a staple in the management of chronic pain, especially for cancer patients. When crushed and injected, snorted or swallowed, however, the medication's time-release effects are short-circuited, producing a heroin-like high.
The federal government estimates that of the almost 500,000 emergency room visits attributed to abuse of pharmaceuticals in 2004, more than 36,000 involved oxycodone. Stolen from medicine cabinets or ordered illegally online, prescription drugs have become a favorite of high school and college students, ranking second only to marijuana among abused drugs, according to the U.S. Drug Enforcement Administration.
"They don't have the stigma of heroin or cocaine," DEA spokesman Garrison Courtney said. "They think because it's something doctors use, it doesn't have the same risks associated with those other drugs." Last month, a robber cleaned out a Costa Mesa drugstore's entire stock of OxyContin. A few weeks earlier, a man was arrested in connection with a string of Orange County pharmacy burglaries in which OxyContin was among the targeted drugs. Last spring, Limbaugh settled a drug fraud charge related to whether he had illegally obtained OxyContin. Love pleaded guilty to possessing the drug without a proper prescription. Also Thursday, the U.S. Food and Drug Administration warned consumers not to use True Man or Energy Max dietary supplements, which are touted as treatments for erectile dysfunction. The agency said the products, which it said were distributed by America True Man Health Inc. of West Covina, contained ingredients that could lower blood pressure to dangerous levels in some users.
The company could not be reached for comment.