FDA Covers Up Report - Mosholder: 'Antidepressants Double Suicides in Children'
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HealthPharma According to a recent article published in the British Medical Journal, a scientific report by one of its researchers, Dr. Andrew Mosholder, showing that antidepressant drugs double the suicide rate in children taking them, was suppressed by the FDA. Instead of owning up to its mistake and issuing generalized warnings, the agency has launched a criminal investigation to find out which employees leaked Dr. Mosholder's report. Apart from the FDA's dishonesty in dealing with drug side effects, we should take a serious look at the practice of prescribing drugs to children, which is based on a flawed paradigm of "abnormal" behavior being caused by chemical imbalances in the brain, to be "corrected" by tweaking little understood biological pathways and blocking receptors of neuronal activity. An excellent report on this is the article by Fred A. Baughman Jr., MD, HISTORY OF THE FRAUD OF BIOLOGICAL PSYCHIATRY. I also want to call your attention to an excellent commentary on this tragic aberration of our 'control society' that is killing and incapacitating hundreds of thousands, both children and adults. Jon Rappoport is mincing no words and he has collected some good data to back up his contention. I recommend Jon's site nomorefakenews.com to anyone willing to wake up to the facts of what is really happening. A word of advice: If you are tempted to dismiss Rappoport's comentary as exaggerated, read right on to the supporting articles. You will come to appreciate that something is awfully wrong here... Here is the commentary by Jon Rappoport KILL YOURSELF AUGUST 11, 2004. It’s war. War against the people. War against children. War against parents. War against families. CHEMICAL WARFARE. I’ve been documenting it and screaming about it since this site started. It’s eating into America. Day by day. It’s mind control. It’s mind scrambling. It’s chemical destruction of minds. And most of the naïve American populace is eating it up, wanting it, asking for it, begging for it. The scum who wage this war are the lowest of the low. The ciphers who assist in the war, who follow the marching orders, are like the “good Germans” who stood by as the little Hitlers took over and started the murders. The faceless bureaucrats who do their part in forwarding the war have their eyes on the federal money that will come to their agencies. The psychiatrists who are the agents in the war should be wearing black uniforms and boots. They have long ago given up rational thought and have opted for pure control. Let them control each other on a desert island and hack each other to pieces. And let us not forget the dupes, the actors and other celebs, the pols who front for this operation under the rubric of “share and care” and “good science.” Let me tell you something. This is the same science that created the eugenics monsters. This is the same science that created the concentration camps. This is the same science that created “mental illness” as a rationale for putting people behind medical bars who disagreed with the power of the State. This is sheer madness perpetrated by those claiming to be able to define sanity and insanity. This is truly the Century of the Brain. As in, dissect the brain, map it, drug it. This is Clockwork Orange in progress. Don’t write me and ask what you can do. You can find a good group of decent people who are already organized and you can join them and become part of the struggle. From the halls of Ritalin to the shores of Prozac. If you’re a shrink who routinely dispenses psychotropic drugs, kill yourself. Really. Kill yourself. Do us all a favor. Overdose on a few of your own drugs and take yourself out. Right now. Don’t delay. Wipe yourself out. Then, look around as you float in the ether and take stock of what you’ve been doing. Maybe you can right your ship then. But meanwhile, kill yourself. Don’t bother to leave a note. Just do it. We don’t need explanations. We know all about it. We know the score. You’re a blight on the human scene. You’re a bug. You’re a scorpion with a few degrees on the wall. Kill yourself. Here is a release from AHRP: ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full disclosure http://www.ahrp.org The Boston Globe reports that 2/3 of children in state care in Massachusetts are being "treated" for mental illness with psychotropic drugs. Marie Parente, a legislator, and parents call for disclosure of "how many children in state care are being given psychotropic drugs, and for government agencies to take a critical look at the procedures for allowing these medicines to be prescribed." Parente suggested that "the state may be motivated to label children as mentally ill because of the reimbursement checks they receive from the federal government, which compensates Massachusetts for half of all Medicaid expenditures." (below) If psychiatry is sometimes regarded as "a mirror of society," then America is mindlessly heading in the wrong direction, driven by an unproven biochemical theory for mental illness. Inasmuch as psychiatry lacks scientific diagnostic tools, and no proven cures or safe medicines, the skyrocketing prescribing of harmful psychotropic drugs to America's children can only be classified as child abuse. [1, 2] Spiraling state Medicaid expenditures for psychotropic drugs are best explained by the drug industry's inordinate influence on psychiatric practice--not these drugs' effectiveness.[3] Dr. Irwin Savodnik, a psychiatrist and philosopher who teaches at UCLA, has studied the shifting winds in psychiatry in the former Soviet Union. He found, that once psychiatrists were freed from Soviet dictatorship in 1992, they shed the straightjacket of "biological determinism." Today, those psychiatrists are avidly reading Freud in an effort to regain a humanistic perspective of human nature that biological psychiatry had eradicated. "The great irony," Dr. Savodnik observes, "is that American psychiatry is moving in exactly the opposite direction. In the past 30 years, the overriding ideology of American psychiatry has shifted to a biological model. Psychopharmacology has become its therapeutic backbone." Dr. Savodnik points out, that the problem is that "this model doesn't tolerate free agency. It views psychiatric problems -- moral problems, really -- as medical ones, just as Soviet psychiatry did." "The Soviet example places in bold relief the deficiencies and fallacies of a truncated view of human life ... as the Soviet system came undone and its psychiatrists freed themselves from the confines of a strangulating ideology, American psychiatrists have embraced uncritically the same narrow vision. But as the Soviet example demonstrates with distressing clarity, a conception of people as little more than biochemical bundles fails to address those aspects of ourselves that make us human." Soviet psychiatry was used primarily as a political tool to control dissident adults: psychotropic drugs were used to punish political dissidents and others the government deemed to be "troublemakers." American psychiatry is more ambitious than Soviet psychiatry ever was. US psychiatrists collaborate with government agencies by providing a seal of approval for involuntary "treatment" of persons loosely deemed to have a "mental disorder", or to be unruly. US psychiatrists also collaborate in the formulation of state-sponsored mental health policies--such as, "screening for mental illness" -- initiatives which primarily target children. In Illinois, pregnant women are targeted for screening as well. [4] Psychiatrists serve as experts on pharmaceutical industry sponsored "consensus" panels, issuing practice guidelines that promote the extensive use of psychotropic drugs to control behavior-and to enrich the drug industry. [5] For these services, the drug industry provides psychiatry with high financial rewards. The most expansive (and expensive) US mental health initiatives are sure-bet profit enhancers: Leading psychiatrists, primarily from the University of Texas, backed by funding from Eli Lilly, Johnson & Johnson and 9 other major pharmaceutical companies, formulated the Texas Medication Algorithm Project (TMAP). [5] TMAP is a template for physicians, purporting to improve their prescribing practices for antipsychotics, antidepressants, mood stabilizers, stimulants, anticonvulsants and other psychotropic drugs. TMAP has been endorsed by a dozen or so, state mental health agencies, and by President Bush's New Freedom Commission on Mental Health (NFC). The TMAP algorithm model "is limited to medication strategies," and TMAP recommendations require the use of the most expensive (profit generating) psychotropic drugs. For depressed children, TMAP recommends SSRI antidepressants as first line treatment "because of supporting efficacy data" from fluoxetine, paroxetine and sertraline. [5] This statement is patently false as the scientific evidence refutes it. [6, 7] NCF recommends mass screening for hidden mental illness -- with emphasis on school children. [8] This dubious initiative is a radical invasion of privacy, leaving no room for individual choice -- or the freedom for parents to say no, to psychotropic drugs for their children. [4] Such mandatory, government-endorsed screening programs contradict the freedoms guaranteed in a democratic society. If implemented, this "new freedom" initiative establishes a coercive selection policy that opens the door to discrimination and forced treatment with powerful, psychotropic drugs that have caused more harm to children (and adults) than the conditions for which they were prescribed. Children and adults who will be labeled mentally ill on the basis of unreliable, subjective tests (essentially questionnaires), can expect to lose their autonomy as a brigade of mental health providers intrudes on their lives and takes over their decision-making authority. It is insidious because the built-in full employment incentive for the mental health service industry-including psychiatrists, psychologists and social workers-is dependent upon taking away freedom from those declared "mentally ill." Inasmuch as drugs are the backbone of psychiatric treatment in the US, screening for mental illness is a strategy that will increase drug sales. The TMAP psychotropic drug guidelines promote the increased use of particular antidepressants and antipsychotics -- even as the evidence raises doubts about these drugs' safety and therapeutic efficacy. Ironically, the failed Soviet approach of using psychotropic drugs to subdue political critics, is now being applied en masse in America -- vulnerable children are especially targeted. Just as Soviet psychiatrists disregarded the harm done to patients, American psychiatrists who embrace the same dehumanizing biological approach disregard known and foreseeable adverse consequences. American psychiatry (and the mental health industry) has an added motivation that the Soviets lacked; namely, a financial stake in the profitability of the pharmaceutical industry. A Whistleblower Report by Allen Jones, the fired Investigator in the Office of the Inspector General (PA), documents the pharmaceutical/political alliance that led to the dubious recommendations of TMAP and NFC: http://psychrights.org/Drugs/AllenJonesTMAPJanuary20.pdf An editorial in Psychiatric News confirms Allen Jones' allegations that TMAP is a pharmaceutical industry funded model. It helps explain why TMAP is biased toward the most expensive drugs and why state Medicaid budgets are being depleted by TMAP recommended drugs: "TMAP received a total of $285,000 from 11 pharmaceutical companies for start-up of the project. In the development of the guidelines for depression, schizophrenia, bipolar disorder, ADHD, and pediatric depression, TMAP to date has spent more than $6 million. The list of funding sources is long." [9] References:
1. Prozac Found In System Of CYA [California Youth Authority] Teens Found Dead - Drugs forced on children without parental permission. Feb. 26, 2004
http://www.thekcrachannel.com/news/2878886/detail.html 2. Lawsuit: State fired shrink for exposing abuse By NICOLE WEISENSEEEGAN.
Philadelphia Daily News:
http://www.philly.com/mld/dailynews/news/local/9095033.htm; 3. Florida Medicaid Mental Health Drug Recommendations, FY 2004-2005
http://tinyurl.com/5p23f 4. IL launches compulsory mental health screening for children and pregnant
women Monday, July 19, 2004.
http://www.illinoisleader.com/news/newsview.asp?c=17748 5. The Texas Children's Medication Algorithm Project: Report of the Texas
Consensus Conference Panel on Medication Treatment of Childhood Major
Depressive Disorder. Carroll W. Hughes. Journal of the American Academy of
Child and Adolescent Psychiatry Nov, 1999.
http://www.mhmr.state.tx.us/centraloffice/medicaldirector/cmappub.html 6. Jon N Jureidini, Christopher J Doecke, Peter R Mansfield, Michelle M
Haby, David B Menkes, Anne L Tonkin, Efficacy and safety of antidepressants
for children and Adolescents, British Medical Journal, online free at:
http://bmj.bmjjournals.com/cgi/content/full/328/7444/879? 7. Craig J Whittington, Tim Kendall, Peter Fonagy, David Cottrell, Andrew
Cotgrove, Ellen Boddington. Selective serotonin reuptake inhibitors in
childhood depression: systematic review of published versus unpublished
data. The Lancet. Volume 363, Number 9418, April 24, 2004, online free at:
http://www.thelancet.com/journal/journal.isa 8. Bush Plans to Screen Whole US Population for Mental Illness by Jeanne
Lenzer - BMJ 2004;328:1458 (19 June)
http://bmj.bmjjournals.com/cgi/content/full/328/7454/1458 9. Putting Clinical Trial Results in Perspective. Psychiatric News August 6,
2004 Volume 39 Number 15, p.35.
http://pn.psychiatryonline.org/cgi/content/full/39/15/35-a
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org
~~~~~~~~~~~~~
THE BOSTON GLOBE
Prevalence of drugs for DSS wards questioned
By Jessica E. Vascellaro, Globe Correspondent August 9, 2004
A lawmaker and some parents are calling on the Commonwealth to disclose how many children in state care are being given psychotropic drugs, and for government agencies to take a critical look at the procedures for allowing these medicines to be prescribed. They cite what they call an alarming statistic about the number of children in the care of the state Department of Social Services who are being treated for mental illness. Figures from the Massachusetts Behavioral Health Partnership, an organization contracted by DSS to coordinate mental health coverage for children in foster care, guardianship programs, and some adoption cases, show that almost two-thirds of children in DSS care received either inpatient or outpatient mental health counseling or treatment during the 2003 fiscal year. According to the data, the partnership provided 12,722 of 19,856 DSS children with mental health counseling or treatment. The organization says it does not keep track of how many children are prescribed psychotropic medicines such as Ritalin, Adderall, and Prozac.
"We need to look into the use of these drugs on children," said state Representative Marie Parente, chairwoman of the state special committee on foster care. "We need a commission to examine the whole practice of administering these psychotropic drugs to children in foster care." Parente said the two-thirds percentage demands a closer look because it is inordinately high, compared with the incidence of mental health disorders in the general population. For example, the National Institute of Mental Health estimates that up to 2.5 percent of children and up to 8.3 percent of adolescents in the United States suffer from depression, and 4.1 percent of 9- to 17-year-olds suffer from attention deficit hyperactivity disorder, two of the most common mental illnesses for which the young are treated. "Many children come from problem homes, but the children are really fine," said Parente. But Dr. Elizabeth Childs, commissioner of the state's Department of Mental Health, said the high number of children in state care receiving mental health services is logical, given the children's tumultuous family histories. "These numbers are absolutely high, but if anything we need a heightened awareness, since these children might have an increased need for mental health services," she said. "I would rather see that we did intervene with 64 percent of the children than have 50 percent of the children who need access not get it." For the past two years, Parente has sponsored state budget amendments that would create a task force to study how many children in state care are prescribed psychotropic drugs. After her latest measure was approved by the House and the Senate, Governor Mitt Romney vetoed the amendment earlier this summer. Richard Powers, spokesman for the state Executive Office of Health and Human Services, said the governor supported an investigation but opposed the creation of a task force.
"We don't oppose the study, but we didn't think a separate study was necessary," he said. "We also thought that a study might be expanded beyond the psychotropics to all medications that children in foster care are taking." Others say they are skeptical of the state's current approach. Gail Wilson-Giarratano of Springfield, who adopted her son in 2002, said that Richard, now 12, came out of the state foster care system on more medications than she could count and that she and her husband have been trying to get him off the prescriptions ever since.
"He has been on meds for so long that nobody knows why they were issued," she said. "He has been labeled as having behaviors he doesn't show." Parente also suggested that the state may be motivated to label children as mentally ill because of the reimbursement checks they receive from the federal government, which compensates Massachusetts for half of all Medicaid expenditures. She said the state files a pre-expenditure report outlining expected costs and each patient's eligibility for Medicaid and other federal aid. While the state is not reimbursed until it submits a report of services actually provided, Parente said there is a lot of room for the state to fudge numbers and list services that were never delivered.
"I am very concerned that they not label these children as having mental health problems in order to receive federal reimbursement," she said. Powers said that such suggestions are baseless. "DSS does not label children to get more money," he said, adding that the department depends on the assessment of mental health professionals for medical decisions. While national statistics on the number of children in state care being treated for mental illness do not exist, a 2004 study by the Chapin Hall Center for Children at the University of Chicago found that only 37 percent of 17-year-old foster children surveyed in Illinois, Iowa, and Wisconsin had received psychological and emotional counseling in the last year and almost one-quarter had been prescribed psychiatric drugs. Those numbers are much lower than the two-thirds figure recorded by the Massachusetts Behavioral Health Partnership. Loretta Kowal, a Massachusetts social worker on DSS's professional advisory committee, said Massachusetts doctors strongly endorse the use of psychotropic medicines.
"We have seen them be successful over and over again," she said. "There probably is a belief in the Massachusetts community that when all else fails, you try what's in the cabinet."
MED JOURNAL EDITOR SPEAKS OUT
AUGUST 11, 2004. The LA Times article reprinted below centers on comments by Marcia Angell, former editor of the prestigious New England Journal of Medicine (NEJM). Her comments on the machinations of the drug industry are, therefore, especially important.
She even points out that mental disorders are being invented to sell drugs. Not bad. However, I’m including comments of my own, in caps and brackets. She turns her pen on drug makers; Former New England Journal of Medicine editor Marcia Angell criticizes costs, research and marketing.
Peter Jaret
Special to The Times
9 August 2004
Copyright 2004 The Los Angeles Times
For more than a decade, physician Marcia Angell served as executive editor and then editor in chief of the New England Journal of Medicine, one of the country's most prestigious medical journals. Under her watch, the journal published hundreds of studies of new drugs. It also published blunt editorials harshly critical of the pharmaceutical industry and the way drugs are tested and approved in the United States. [IT ALSO PUBLISHED MANY, MANY ARTICLES WHICH WERE WRITTEN BY “OBJECTIVE” AUTHORS WHO, IN FACT, WERE TAKING MONEY FROM DRUG COMPANIES AS THEY TOUTED THE RESULTS OF DRUGS SOLD BY THOSE VERY COMPANIES. TO SAY THAT NEJM WAS UNAWARE OF THIS GROSS CONFLICT OF INTEREST IS LIKE SAYING A BIRD WATCHER MISSED A CARDINAL BECAUSE HE KEPT HIS BINOCULARS IN HIS POCKET.] Angell left the journal's editorship in 2000, and is now a senior lecturer at Harvard Medical School. She has written a scathing critique of the pharmaceutical industry, "The Truth About the Drug Companies: How They Deceive Us and What to Do About It" (Random House, 2004). In a recent conversation, she talked about why so many of the drugs on the market are so costly, and also about her contention that many of them are not as effective as they're promoted to be. [YES, NOT AS EFFECTIVE. WHAT ABOUT UNSAFE? WHAT ABOUT TOXIC? WHAT ABOUT ‘CAUSE OF DEATH?’] Question: We all know drugs are expensive. But doesn't that reflect the high cost of researching and developing new drugs? Answer: No. That's what the drug makers would like you to think. But it's simply not true. In 2002, the biggest drug companies spent only about 14% of sales on research and development and 31% on what most of them call marketing and administration. They consistently make more in profits than they spend in R&D. And their profits are immense. In 2002, the combined profits of the 10 drug companies in the Fortune 500 were $35.9 billion. That's more than the profits for all the other 490 business put together, if you subtract losses from gains. Q: The system may be flawed, but hasn't it generated hundreds of new medications? A: That's another myth the drug makers would like you to believe. In fact, the number of truly innovative new drugs is quite small. True, many drugs are coming to market. But most of them aren't new at all. They are minor variations of bestselling drugs that are already on the market. There are dozens of examples of these "me-too" drugs. There are now six different statins to lower cholesterol. The first, Mevacor, which was approved in 1987, was indeed an innovative drug. Other companies wanted to capitalize on this extremely lucrative market and they began creating other statins. Lipitor is now the biggest-selling drug in the world. But it's a me-too drug. There's little scientific evidence that any of them is better than the others in comparable doses. [AGAIN, SHE LEAVES OUT TOXICITY.] Q: Doesn't the Food and Drug Administration require new drugs to be safer and more effective than drugs already on the market? A: It should, but it doesn't. Drug makers are only required to show that a new medication is more effective than a placebo, or sugar pill. If a drug works better than a placebo and is safe, the FDA approves it, and it can enter the market. The result is that doctors don't know if a new drug that comes along is any better or worse than the drugs they're already using. A dark fear I have, in fact, is that drugs are getting progressively worse. There's some basis for that concern. The first drugs used to lower blood pressure were diuretics. Then new drugs for hypertension came along and were heavily marketed, and many doctors stopped using diuretics. In a study published in 2002, researchers compared the old drugs to the new ones, and guess what -- the old drugs turned out to be just as good for lowering blood pressure and even better than the new drugs for preventing some of its complications. [SHE LETS DOCTORS OFF THE HOOK. DOCTORS ARE SMART ENOUGH TO SEE THROUGH THE RUSE --- IF THEY WANT TO.] Q: Why do drug makers churn out new drugs when older ones work perfectly well? A: Because patents run out on older drugs and they can then be sold as generics at as little as 20% of the price [they sold at while still under patent]. Pharmaceutical manufacturers need a constant supply of new drugs that have patent protection so they can charge whatever they want. Q: Isn't it useful to have a variety of drugs to choose from, in case a patient doesn't respond to the first? A: That's an argument the pharmaceutical industry makes -- that it's good to have six cholesterol-lowering drugs, or five selective serotonin reuptake inhibitors (SSRIs), the antidepressants that include Prozac, Zoloft and Paxil. But if that's true, then the companies should be required to test a new me-too drug in people who failed to respond to the first drug. And they don't do that. My guess is that if the first drug doesn't work, the second one won't work either, since me-too drugs are so similar. But no one can say for sure. Q: What about competition? Do me-too drugs help keep prices down? A: Probably not. When did you see a drug company advertise that its drug is cheaper than another drug? You don't see ads that promote Lipitor as cheaper than Zocor. Or Zoloft as cheaper than Paxil. I can't think of any other industry where price is almost never mentioned. Drug companies compete by implying that their new drug is better. And also by making more people think they need drugs. Consider psychiatric drugs. If you can define everyone who has the blues as having depression that needs to be treated, you've created a huge market. If you define everyone who is shy as having social anxiety disorder, that enlarges the market. There's probably not a soul alive who hasn't felt shy. If you listen to the pharmaceutical industry, many of the ordinary discontents of life are medical conditions that require drugs. You see the same thing with erectile dysfunction. Any episode of impotence, no matter how mild, how rare, becomes a condition, erectile dysfunction, that can be treated. It's no coincidence that the people in those ads tend to be middle aged or even younger. Pushing the disease is a big part of pushing the drugs. The result is that many Americans are probably on too many medications, with all the risks of side effects and drug interactions that implies. Q: If new drugs aren't necessarily better than old ones, why do doctors prescribe them? A: Part of the answer is marketing. New me-too drugs are heavily marketed to patients and doctors. Look at the ads on television. Look at the endless parade of drug representatives marching through doctors' offices. Pharmaceutical companies spend billions and billions to make us think that new drugs are better than old ones. They have to. If you had a drug that was important and unique, you wouldn't have to advertise it very much. If you came out with a cure for cancer, the world would beat a path to your door. So you have to ask, why are drug companies spending so much on marketing? The answer is that they have to convince us that their me-too drugs are better than the others. And that takes a heap of marketing, because there's usually no scientific evidence to back up the claim. [AGAIN---SHE LETS DOCTORS OFF THE HOOK.] Q: It's easier to imagine patients being fooled -- but doctors? A: People don't realize that the pharmaceutical industry supports most of the continuing medical education programs in this country. These are the programs doctors are required to attend to update their knowledge. Drug makers fund the programs, so it's not surprising that they promote a drug-intensive style of medicine. In their offices, doctors are visited by swarms of company sales representatives who bring packages of free samples -- about $10-billion worth a year -- of the newest brand-name drugs. The doctors get used to prescribing them, the patients get used to taking them, and when the free samples run out, someone has to start paying for the drug. Whether these new drugs are actually better than older generic drugs never crosses the doctor's mind or the patient's mind. They confidently believe that newer is better. [BALONEY. DOCTORS KNOW WHAT’S GOING ON. THEY’RE JUST PRETENDING TO BE IGNORANT.] Q: What about clinical trials? Don't they provide evidence about how well drugs work? A: Research is biased in favor of the drugs and drug makers. The pharmaceutical industry spends a great deal to influence people in academic medicine and professional societies. It does a super job of making sure [that] nearly every important person they can find in academic medicine [who] is involved in any way with drugs is hired as a consultant, as a speaker, is placed on an advisory board -- and is paid generous amounts of money. Conflicts of interest are rampant. When the New England Journal of Medicine published a study of antidepressants, we didn't have room to print all the authors' conflict-of-interest disclosures. We had to refer people to the website. I wrote an editorial for the journal, titled "Is Academic Medicine for Sale?" Someone wrote a letter to the editor that answered the question, "No. The current owner is very happy with it." That sums up the situation nicely. [SO WHY DID IT TAKE SO LONG FOR NEJM TO RAISE A FLAG OF WARNING ABOUT RESEARCH CONFLICTS OF INTEREST?] Q: What can be done to fix the system? A: The single most important change that should be made -- and it could be made tomorrow -- is for Congress to redefine what safe and effective means, to insist that the FDA require manufacturers to test new drugs not just against placebos but against existing drugs. After all, the relevant issue isn't whether a new drug works better than nothing; it's whether it's better than older drugs already in use. That's why so many clinical trials published are of no use to doctors. Doctors don't want to know if this new drug is better than a sugar pill. They want to know if it's better than the drug they're already using. The FDA should require manufacturers to compare new drugs head to head, at equivalent doses. Only drugs that are safer, more effective, or significantly more convenient, should be approved. We also need to make the FDA more independent. The FDA has 18 advisory committees, and many of the members of those committee have financial ties to the drug industry. That's wrong. Finally, university medical centers and medical societies and the people who run them need to stop fooling themselves into thinking they can take huge sums of money from drug makers and still remain objective and independent. [FACE IT. IF THESE FDA-APPROVED DRUGS ARE KILLING PEOPLE AT THE RATE OF 100,000 A YEAR IN THE US, THERE IS AN ONGOING RICO CRIME AT THE FDA. THE WHOLE SYSTEM IS CORRUPT. FOR EXAMPLE, DRUG COMPANIES ROUTINELY SUPPRESS THEIR OWN DRUG STUDIES WHEN THE RESULTS ARE NEGATIVE.] Q: Is there anything patients can do? A: Ask questions. If your doctor prescribes a medication, ask about the evidence that shows it is effective. Ask why your doctor is prescribing this particular drug. Ask if there are older, less expensive drugs that might work just as well. A few questions from patients might begin to make [doctors] think about what they're doing. Finally, ask your doctor whether you really need a drug at all. Maybe a lifestyle change would be better, or maybe the illness is mild and will go away on its own. [SHE NEGLECTS TO MENTION THAT AT LEAST SEVERAL MILLION PEOPLE IN THE US ARE PUTTING THEIR HEALTH TOGETHER WITH THE USE OF NUTRIENTS, NOT DRUGS. AND THERE IS A DE FACTO BAN ON TESTING THESE NUTRIENTS IN MAJOR STUDIES.] End of Times article Comments in [ ] are by JON RAPPOPORT www.nomorefakenews.com
See also related:
Glaxo settles New York drug suit
GlaxoSmithKline has agreed to publish results of clinical tests on its drugs, to settle a US lawsuit. The firm was sued by New York attorney-general Eliot Spitzer over allegations that it withheld negative information about its antidepressant pill, Paxil. Depression
Depression is the most frequently searched-for topic at DoctorYourself.com. And no wonder. Those of us that have experienced the depths of clinical depression know just how awful it really is. When you are in the bag, it is hard to think out of the bag. But there is a way out... Antidepressants dangerous and should be banned, crusader says
By Elaine Jarvik - Deseret Morning News
Ann Tracy knows hundreds of grisly stories: the professor on Prozac who bit her mother to death; the Stanford graduate on Paxil who stabbed herself in the kitchen while her parents slept; the mother who bludgeoned her son and then drank a can of Drano; the 12-year-old girl who strangled herself with a bungee cord... FDA Rules Antidepressant Did Not Play Role in Woman's Suicide During Eli Lilly Clinical Trial - Wonder what that suicide was caused by if not the effects of the drug - which is now approved for general sale... BRITISH MEDICAL JOURNAL - AUGUST 7, 2004 - Secret US report surfaces on antidepressants in children Fred A. Baughman Jr., MD, HISTORY OF THE FRAUD OF BIOLOGICAL PSYCHIATRY
Not exactly related to psychiatric drugs, but to show where the mentality of a drug society eventually leads:
AIDS Experiments on Children in New York's Incarnation Center 'A Human Tragedy'
SSRI Citizen announces antidepressant “Unsafe At Any Dose” national awareness campaign. Dangers of Paxil, Zoloft, Prozac and Effexor are targeted by group. THE WHITE COATS ARE COMING! - Jon Rappoport FDA Study Confirms Antidepressant Risks - Washington Post Anti-depressants could hurt unborn infants IL launches compulsory mental health screening for children and pregnant women Children's Mental Health task force hearings continue through Friday Some doctors weigh in on mental health screening Antidepressant Study Seen to Back Expert Anti-depressant deaths increase - Rise in venlafaxine-related deaths: A popular anti-depressant has been linked with growing numbers of suicides and accidental overdoses, statistics show. Between 1993 and 2002, 118 people in England and Wales taking venlafaxine (Efexor) died - 17.6 deaths per million prescriptions. Prozac Nation? Is the Party Over? - by Richard C. Morais, 09.06.04 Forbes Magazine Aug 15, 2004 - Mosholder Report - M E M O R A N D U M
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PID# D040495 (Download PDF version from FDA's site) Secret US report surfaces on antidepressants in children WALL STREET JOURNAL - September 28, 2004
FDA to Probe Antidepressant Risks for Adults - After Planning Warning for Kids, Agency to Re-Examine Evidence Suggesting No Danger of Suicide See also this release by Alliance for Human Research Protection: Dr. Andrew Mosholder is but the most recent example to come to light, of an FDA medical officer whose expert analysis and recommendations were suppressed by the agency because the recommendations might affect the financial interests of a drug manufacturer. Dr. Mosholder was asked to analyze the Paxil data in Sept. 2003, after the British regulatory agency examined the clinical trial data and found a suicidal risk for children / adolescents prescribed Paxil / paroxetine. The British issued a prohibition on the use of Paxil for children (June 2003). Dr. Mosholder then analyzed the suicidal behavior data submitted by drug manufacturers of 9 different antidepressants to the FDA from 22 randomized, placebo-controlled clinical trials. In these trials, 4,250 children / adolescents participated: 2,298 were given an active drug, and 1,952 were given a placebo. Dr. Mosholder found that 108 child-patients suffered suicide-related events: 74 were on active drug, and 34 on placebo. Of these, 78 were serious adverse events--54 occurred in children taking an active drug, compared to 24 on placebo. Children on an antidepressant were at greater than twofold increased risk of drug-induced suicidal behavior. Inasmuch as the drugs -- with the possible exception of Prozac* -- have failed to demonstrate a benefit in clinical trials, these serious risks are not offset by any scientifically proven benefit for children. Therefore, a minimal precautionary action would require prominent warnings to physicians and families. Dr. Anne Trontell, Director, Div. Of Neuropharmacological Drug Products, and Dr. Mark Avigan, Director, Div. Drug Risk Evaluation, concurred with Dr. Mosholder's analysis and conclusions, but disagreed that physicians and families should be warned about these risks. Dr. Mosholder's medically responsible, science-based recommendation: "Given the strength of the association shown by the present data, the clinical importance of the apparent effect...and the fact that the additional analyses are likely to take several more months to complete while considerable numbers of pediatric patients are being exposed to these drugs, I favor an interim risk management plan regarding the use of these drugs in the pediatric population. This might be of value to physicians, patients and families who are faced with the need to make a decision regarding pharmacotherapy at the present time. Specifically, I propose a risk management strategy directed at discouraging the off-label pediatric use of antidepressant drugs, particularly the use of drugs other than fluoxetine in the treatment of pediatric MDD [major depressive disorder]. Conceivably, this might include discouraging the initiation of treatment of drug-naive pediatric MDD patients with off-label drugs, in the absence of some over-riding clinical consideration." Dr. Mosholder's embargoed report and the accompanying Trontell and Avigan memos are posted on the AHRP website at: http://www.ahrp.org/risks/SSRImosholder/index.html
Of note: FDA's chief counsel, Daniel Troy, is the architect of the administration's aggressive intervention in court on the side of drug and medical device manufacturers. Troy is one of over 100 top government regulators appointed by the Bush administration, who were identified as advocates for the industries they are supposed to regulate.
See: Anne Mulkern, When Advocates Become Regulators. Denver Post, May 14, 2004.
See also: Jeanne Lenzer, FDA's counsel accused of being too close to drug industry BMJ, July 24, 2004
Examples refuting the basis of FDA's pre-emption argument: FDA's decisions about drug safety are not always based on scientific evidence. All too often FDA decisions result in preventable deaths:
REZULIN: How a New Policy Led to Seven Deadly Drugs PROPULSID: A Heartburn Drug, Now Linked to Children's Deaths;
http://my.webmd.com/content/article/22/1728_55973 FEN-PHEN: http://www.legalnewswatch.com/news_401.html (substitute for expired link - Sepp) (PPA): www.latimes.com/ RISPERDAL (risperidone); ZYPREXA (olanzapine):
http://www.ahrp.org/infomail/0702/12b.html *It should be noted that in Dec. 2003, Eli Lilly, manufacturer of Prozac, issued a label change in the UK stating, Prozac is NOT recommended for children. See:
http://www.ahrp.org/risks/ProzacKids1203.html Contact: Vera Hassner Sharav
e-mail: veracare@ahrp.org
See also related:
HOW PAXIL KILLED OUR SON CATIE & You
What happens when drugs are found to be unsafe and ineffective? Not much. No Child Left Unmedicated
By: Phyllis Schlafly - Published In: Health Care News
Publication Date: March 1, 2005
Big Brother is on the march. A plan to subject all children to mental health screening is underway, and the pharmaceutical firms are gearing up for bigger sales of psychotropic drugs. Like most liberal, big-spending ideas, this one was slipped into the law under cover of soft semantics. Its genesis was the New Freedom Commission on Mental Health (NFCMH), created by President George W. Bush in 2002. Washington Post, September 13
Experts had previously said that studies of Prozac found no increase in suicidal tendencies, but its unique status came into question yesterday. Hammad testified that a recent government-sponsored study, which researchers had described as convincing evidence of Prozac's effectiveness, found that it carried the same risk of triggering suicidal behavior as other drugs. Washington Post, September 9
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 the drugs were no better than sugar pills, according to documents and testimony released at a congressional hearing yesterday. The Role of the FDA
The Claim There is "No Scientific Evidence" for Alternative Treatments... Attorney questions FDA probe of Lilly - Family of drug trial suicide victim says it wasn't consulted; details of investigation still unreleased. FDA suppressed antidepressant risks, panel says Antidepressants Linked to Withdrawals in Newborns, Study Says
Feb. 4 (Bloomberg) -- GlaxoSmithKline Plc's Paxil, Eli Lilly & Co.'s Prozac and other antidepressants may cause convulsions and other withdrawal symptoms in newborns whose mothers took the drugs during pregnancy, according to a study in the Lancet medical journal. FDA - Lights on, nobody home
We were shocked, SHOCKED to learn that psychiatric drugs have psychiatric side effects!! And that the FDA is going to ask drug makers to include questions about suicidality in clinical trials of some new drugs. In the new spirit of transparency, FDA officials would not say which drugs or how many drugs would be examined.
http://www.communicationagents.com/sepp/2004/08/12/fda_covers_up_report_mosholder_antidepressants_double_suicides_in_children.htm
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