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Offline Antigen

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FDA warning on SSRIs
« Reply #90 on: November 25, 2003, 06:54:00 PM »
I just started reading this and had to share...

Giant Floating Purple Pills



Are those creepy prescription-drug commercials on TV trying to kill you?  

By Mark Morford,

SF Gate
Columnist
Friday, November 21, 2003
 
Cut to picture of healthy-looking yuppie guy emerging from swimming pool and smiling.

Cut to picture of mother twirling her child in the park in slo-mo. Cut to picture of woman taking deep whiffs of fresh-cut lilies at the florist and grinning warmly as if the world was one big gob of perky happy fluffy bunny joy. Yay. Drugs. Yay.

Celebrex can make you feel like you again. Celebrex is a revolutionary new breakthrough in medicine technology. Celebrex is not for everyone. Ask your doctor if Celebrex is right for you.

Side effects may include nausea diarrhea anxiety sleeplessness headaches projectile vomiting genital warts narcolepsy halitosis death bed wetting pained nightmares involving angry bloodsucking poodles and the mad uncontrollable desire to smash your head into a brick wall over and over again until you stop screaming.

Do not use Celebrex if you are recently deceased. Do not use Celebrex if you are already experiencing heart palpitations or night sweats or screaming terrified wolf howls or if you take any other medication that begins with the letter C.

Pregnant or nursing mothers should not use Celebrex, unless you want your child to become a mutant deformed pygmy three-armed libertarian with 17 toes and the IQ of a small canned ham.

If you are absolutely certain nothing is wrong with you and you feel fine and hence you do not need Celebrex, this is actually the first troubling sign that Celebrex is exactly what you need. Contact your doctor immediately, if not sooner.

If you are right now watching this TV commercial for Celebrex and have no idea what the hell Celebrex is because we don't ever actually tell you what the hell it is, and, hence, if you feel the pharmaceutical industry is this freakish mega-powerful mind-control cult fully bent on convincing as much of the human population as possible that wildly expensive prescription meds are the answer to all your problems, this, too, means you should take our medication, pronto.

And if you go so far as to dare to think that maybe, just maybe, alternative medicine or homeopathy or just becoming much, much more aware of your life and what you eat and how you live might, in fact, negate the need for a great many of the drugs we manufacture, and if you believe that we might actually invent bogus ailments and drill a fear of them into the cultural consciousness, all in order to supply you with the narcotics to treat them, well, have we got a nice pill for you.

Sound familiar? It should. It was in 1997 that the FDA finally loosened the rules on DTCA (direct-to-consumer advertising), finally let them loose upon the unsuspecting and completely unprepared populace, and thus were major pharmaceutical companies given the right to advertise like savage and shameless maniacs on national television.

And they were allowed to hawk extremely expensive and often toxic drugs designed to relieve you of various debilitating ailments, but not even really tell you what those products actually do, or why, or how much they cost, or anything at all except for a quick charming listing of possible side effects, each of which seems to involve some sort of stomach recoil and skin eruption and painful bowel shift.

But there was a study. There is always a study. By the Kaiser Family Foundation. A couple years ago. It said that one in eight people who saw a drug commercial on TV did, in fact, ask their doctor about it, and 44 percent of those actually got themselves a prescription for that drug.

Sadly enough, drug ads work. In 1997, pharmcos spent $791 million on TV ads. Today that figure is well over $3 billion. This is why you can't turn on the TV without seeing some inexplicable commercial for some bizarre-sounding drug that features as its active ingredient siflintrate oxygtoralnyzincotim but which they call Happium or maybe Numbium. Drugs have become just another everyday consumer good, like Campbell's soup or Windex or a new Toyota Camry.

A swarm of giant purple pills gently fall from the azure sky, rotating slowly as they fall, like a rain of Skittles, like manna from the gods of Merck. A well-drugged housewife happily bakes cookies with her children as a bird sings on the windowsill. Happy narcotized citizens of America go about their business, usually in slow motion, always grinning calmly, the colors of the world oversaturated and utopian and creepy.

Lipitor. Nexium. Singulair. Vioxx. Vanceril. Xenical. Zyrtec. Allegra. Avandia. Claritin. Zoloft. Ritalin. Valtrex. Viagra. Flonase. Prinivil. Meridia. Prilosec. Provocal. Ditropan. All on TV. All aimed straight at consumers. All sounding like a new model from Acura.

Many of these drugs are, of course, beneficial to a great many people, but every single one crosses over that modest boundary of limited need and is heavily overmarketed and overprescribed and wickedly expensive, its promised results misleading and even dangerous.

And many of these drugs are, in the long haul, quite likely more toxic and destructive to the mind and body than pot or cocaine or ecstasy. But, hey, as every major oil CEO and BushCo warmonger and Wal-Mart exec knows, education and common sense are the true enemies of profit.

Simply put, it is in the vested interest of every pharmco in the world to convince as many doctors as possible to prescribe their drugs, wining and dining them and sending them elaborate gifts and buying them hookers and booze and cars and lost weekends during ridiculously lavish weeklong drug symposiums at the Bellagio in Vegas. Hey, just ask any M.D. -- this happens far, far more than you think.      

And, by the way, you have not seen the very embodiment of slick smarm until you've met a professionally groomed and carefully hatched drug rep from a major pharmaceutical corporation. Beware.

But now, much to their overall sinister glee, pharmcos no longer have to market solely to doctors. And they can also pass right over your neighborhood pharmacist, the specialist who's actually specifically trained in this sort of thing, who actually knows more than almost any doctor about prescription meds and what chemical does what to whom and why.

After all, why try to convince the wary professionals and experts when you can market straight to the gullible and the trusting and the easily duped? America is sick sick sick, besotted by a hundred thousand ailments, each one more icky and ravaging than the last. This is what they are selling. This is the underlying message. This is why you need their drugs.

And this is why television is their ultimate medium, allowing them to convince as many consumers as possible that they must demand a prescription for that neat-o pretty purple pill they saw on TV because, as we all know, if it's on television, it must be good.

We have become a nation completely inured to seeing giant pretty pills floating across our TV screens like they were just another can of Cheez-Whiz. Hell, even the FDA says many of these ads are seriously misleading, and has issued numerous warning letters to countless pharmcos for intentionally lying to consumers about the efficacy of their chemicals.

No matter. Few are demanding any drastic change to the ads, as Bush-backed corporations have more power than they've had since the industrial revolution, and, hence, nuanced awareness of corporate calculation, of what is being sold to us -- from war to jingoist ideology to the mountain of legal drugs we happily pump into our bodies -- seems to be at an all-time low.

But it's OK. That sadness and bitterness and overall disgust you might feel about all this? That sense that you are losing control, that they have far too much power and reach and you have too few defenses and they will soon be marketing Ritalin and kiddie Prozac straight to your child during "Spongebob" commercial breaks? Fear not. Just relax. They have a pill for that, too.

G:   "If we do happen to step on a mine, Sir, what do we do?"
EB:  "Normal procedure, Lieutenant, is to jump 200 feet in the air and scatter oneself over a wide area."
-- Somewhere in No Man's Land, BA4

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"Don\'t let the past remind us of what we are not now."
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Offline Deborah

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FDA warning on SSRIs
« Reply #91 on: November 25, 2003, 11:56:00 PM »
ROFLOL!!! Thanks for the humor. I love Morford-right up there with Dave Berry whose piece on SUVs was side splitting!!

Back to Utah for a moment- Hatch and Ashcroft accept fat donations from drug companies.

http://www.drugawareness.org/Archives/2 ... d0030.html
Excerpts- more at the link:
Two Republican senators - John Ashcroft of Missouri and Orrin Hatch of Utah - are the latest to come under fire for accepting fat donations from America's drug industry.

Senator Ashcroft was labeled "the Fortune 500 senator" this week by Green Party presidential candidate Ralph Nader after a big drugmaker gave $50,000 to the Ashcroft Victory Committee.

Senator Hatch has spent recent weeks fending off critics who charged that he was quietly trying to help the same drugmaker (Schering-Plough) win a patent extension that could be worth billions to the firm. Hatch is chairman of the Senate Judiciary Committee, and Ashcroft is chairman of Judiciary's Subcommittee on Constitution, Federalism, and Property Rights that oversees patent issues. Both senators are up for reelection this year.
***
The question critics ask is: Did Hatch and Ashcroft, in response to those contributions, do the bidding of Schering-Plough while disregarding the impact of their actions on the prices that Americans pay for drugs?

Recently, the spotlight has shone on Hatch. It began when someone in the Senate crafted a bill that would make it easier for drug companies to extend patents, a move opposed by generic drug firms.

The Senior Coalition, alarmed by the draft legislation, offered a $1,000 reward to whomever exposed the name of the senator responsible for producing it. They labeled this mystery person "Senator Anonymous."

After much speculation, Hatch conceded that he was that person. But he insisted that a more accurate name would be "Senator Anonymous, Wrongly Accused." Hatch says he did nothing improper. He explains that his Judiciary Committee staff, without his knowledge, drafted the proposal.

Hatch spokesman Chris Rosche says the draft was only "for the purpose of discussion." It was "far more overreaching than Senator Hatch would ever allow to become law," he says.
****

As the leading recipient of drug industry money in Congress, Hatch had collected more than $169,000 in campaign contributions from pharmaceutical companies as of May 1, according to the Federal Election Commission. Of that, $14,000 came from Schering-Plough. He also used an airplane owned by Schering-Plough during his bid for the 2000 GOP presidential nomination.
****

Critics expect some sort of patent-extension legislation to come up again soon. With this in mind, the group that sponsored the bounty on "Senator Anonymous" says it will donate $1,000 to a senior center in Utah. John Powell, head of The Seniors Coalition, says the money could be used to invite Hatch over for some straight talk from seniors on the "negative effects of unwarranted patent extensions."
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Offline Deborah

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FDA warning on SSRIs
« Reply #92 on: November 27, 2003, 01:24:00 AM »
http://www.mazeministry.com/mormonism/w ... ressed.htm

Other states with high antidepressant use were Maine and Oregon. Utah's rate of antidepressant use was twice the rate of California and nearly three times the rates in New York and New Jersey, the study showed.

WHY?

"The one true answer is we don't know," said Canning [Pres of Utah Psych Assoc], who has a private practice in Logan. "I have some hunches.

"In Mormondom, there is a social expectation--particularly among the females--to put on a mask, say 'Yes' to everything that comes at her and hide the misery and pain. I call it the 'Mother of Zion' syndrome. You are supposed to be perfect because Mrs. Smith across the street can do it and she has three more kids than you and her hair is always in place. I think the cultural issue is very real. There is the expectation that you should be happy, and if you're not happy, you're failing."

Some suggest that Utah's unique Mormon culture--70% of the state's population belongs to the church--requires perfection and the public presentation of a happy face, whatever may be happening privately. The argument goes that women in the Church of Jesus Christ of Latter-day Saints are beset by particular pressures and are not encouraged to acknowledge their struggles.

Utah's large families--the biggest in the nation according to the 2000 Census--are often cited as a contributing factor to depression, again, largely among women. Others call the "harried housewife" explanation the stuff of urban legend.

Utah also leads the nation in the use of narcotic painkillers such as codeine and morphine-based drugs, the study found, and is ranked seventh in total prescriptions overall. Kentucky ranked first.

State officials say the study's results could indicate that this is an enlightened society in which depression and mental illness are destigmatized. In such a social climate, they say, more people are willing to seek help and, eventually, are prescribed drugs.

Cindy Mann, who lives in Logan, said after 15 years of taking antidepressants and not feeling better, she finally quit in July. Today she encourages others to do likewise, but she's pessimistic.

"It's like Happy Valley here," she said, describing the Salt Lake Valley. "It's a scary place sometimes. People don't talk about their problems. Everything is always rosy. That's how we got ourselves into this mess--we're good at ignoring things."

*************************
And check this site. Great humorous and informative stories-- Wild Utah!

http://www.wildutah.net/2-12-02/htmldocs/Mormon.htm

3) Mormons won?t have any part of caffeine, cigarettes or drugs, except prescription drugs like Prozac (it?s depressing to be a Utah Mormon) or methamphetamine (diet drugs are big sellers because not only are Mormon women depressed, they are fat as well ? probably from a combina-tion of too many kids and too many gelatin salads). Mormon men find it?s easier to live with their depressed, fat wives if they take Prozac as well. Besides, if the prescriptions come from their friendly, Mormon physician, it?s OK to be a druggie.

http://www.cbsnews.com/stories/2002/06/ ... 0918.shtml
Utah is known as the "beehive state" because of its residents' proud record of productivity. But some here fear the pressure to achieve may be pushing people too far. And with the nation's ninth highest suicide rate, Utah is even getting the federal government's attention.

The U.S. Surgeon General's special assistant is tracking the problem ? made even more urgent by the latest youth suicide statistics, that found in 2000, 66 young people between the ages of 5 and 24 killed themselves in this sparsely populated state.

For many Utah teens, normal tension relievers, like after school sports, aren't working.

"A few of our friends take anti-depressants just because I think we're not good enough, like we don't think we're good enough, then we turn to other things," said high-schooler Lyndsay Anderson.

Other things can include dangerous drugs. The baseball team at Payson High School has a new starting line up because many of its stars were caught using and selling painkillers.

"I wasn't surprised, but I was disappointed when it started unraveling," says Payson principal Kay Smith. "It was much bigger than I thought it was going to be."

Smith admits her kids are stressed but no more, she says, than other high school students. Still, some teens say it's part of life in Utah.

"If they don't think they're quite living up to the standards that everybody has set for them, then I could see how that could lead to some problems," says high school student McCord Larsen.
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Offline Deborah

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« Reply #93 on: November 29, 2003, 07:18:00 PM »
http://www.dfw.com/mld/startelegram/new ... 036372.htm
Excerpts:

Researchers at Baylor University have found traces of an antidepressant in the livers, muscles and brains of bluegills in a Denton County creek, raising concerns about the welfare of the fish and the people who eat them.

The chemical, fluoxetine hydrochloride, is the active ingredient in Prozac. It likely came from a city of Denton wastewater treatment plant, which discharges into Pecan Creek and flows into Lewisville Lake. Traces of the drug that are not absorbed into the body can flow down the toilet and through wastewater treatment plants, which are not designed to filter out pharmaceuticals.

Fluoxetine and other antidepressants affect fish in roughly the same ways they affect people, said Bryan Brooks, a Baylor toxicologist who led the study.

Eli Lilly and Co., which manufactures Prozac, has a material safety data sheet for fluoxetine hydrochloride on the company Web site. Under environmental information, the data sheet states that the chemical is "moderately toxic to fish and highly toxic to invertebrates and green algae" and can be considered persistent in the environment because of its low rate of biodegradation. The data sheet also states that the chemical has low potential to accumulate in aquatic organisms.

? Can these pharmaceuticals pollute drinking water supplies?

? What are the health effects of eating fish contaminated with pharmaceuticals?

? If fluoxetine is in the bluegills in Pecan Creek, might it also be in the tissues of other species in other waterways?

If it can be confirmed that pharmaceuticals are moving untreated through wastewater plants, sewer plant operators could be required to begin controlling these discharges. That could necessitate the addition of new technology costing millions of dollars and could have a tremendous impact in North Texas.
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Offline Deborah

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« Reply #94 on: November 30, 2003, 09:36:00 PM »
Tomorrow night, Monday, December 1, the International Coalition for Drugawareness will be featured on the Jeff Rense Show. You can listen to this show online at http://www.rense.com.

The show is set for 8-10 PM Pacific Time and will address the serious issue of SSRIs being given to children. This is the subject of the upcoming FDA
hearing on February 2 and all of the guests on the show are scheduled to speak to the FDA Advisory Committee at that February hearing.
 
Along with me several of our directors across the country will be interviewed
- Mark Miller from KS, Tom Woodward from PA, and Lisa Van Syckel from NJ.

Mark and his wife, Cheryl lost their son, Matt, to Zoloft. He began to show signs of mania and akathisia and hung himself after only seven days on the drug.

Tom and Kathy Woodward also lost their daugther after just a week on Zoloft. They had added Deseryl (Trazadone) just two days before. She too hung herself at home.

Lisa's daughter had very serious reactions to SSRIs and her story was featured in the October issue of Good Housekeeping.

Also on the show will be Amy Coburn from UT who just won the Miss Brigham City contest and is now running for Miss Utah. She has made the dangers of drugging of children with psychiatric drugs her platform.

If you miss this show you should know that it will be archived on http://www.rense.com so that you can play it at a later date or recommend it to others
interested in this issue.

Dr. Ann Blake Tracy,
Executive Director, International Coalition For Drug Awareness
& author of Prozac:  Panacea or Pandora? - Our Serotonin Nightmare
& tape on safe withdrawal "Help! I Can't Get Off My Antidepressant!"

Order Number: 1-800-280-0730
Website: http://www.drugawareness.org
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Offline Deborah

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FDA warning on SSRIs
« Reply #95 on: December 11, 2003, 07:35:00 AM »
How drug firms 'hoodwink' medical journals
Antony Barnett
The Observer

Hundreds of articles in medical journals claiming to be written by academics or doctors have been penned by ghostwriters in the pay of drug companies, an Observer inquiry reveals. The journals, bibles of the profession, have huge
influence on which drugs doctors prescribe and the treatment hospitals provide.

But The Observer has uncovered evidence that many articles written by so-called independent academics may have been penned by writers working for agencies which receive huge sums from drug companies to plug their products.

Estimates suggest that almost half of all articles published in journals are by ghostwriters.

While doctors who have put their names to the papers can be paid handsomely for 'lending' their reputations, the ghostwriters remain hidden. They, and the involvement of the pharmaceutical firms, are rarely revealed.

These papers endorsing certain drugs are paraded in front of GPs as independent research to persuade them to prescribe the drugs.
....
Few within the industry are brave enough to break cover. However, Susanna Rees, an editorial assistant with a medical writing agency until 2002, was so concerned about what she witnessed that she posted a letter on the British Medical Journal website.

'Medical writing agencies go to great lengths to disguise the fact that the papers they ghostwrite and submit to journals and conferences are ghostwritten on behalf of pharmaceutical companies and not by the named authors,' she
wrote. 'There is a relatively high success rate for ghostwritten submissions - not outstanding, but consistent.'

Rees said part of her job had been to ensure that any article that was submitted electronically would give no clues as to the origin of the research.
....
One field where ghostwriting is becoming an increasing problem is psychiatry.

Dr David Healy, of the University of Wales, was doing research on the possible dangers of anti-depressants, when a drug manufacturer's representative emailed him with an offer of help.

The email, seen by The Observer, said: 'In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.'
 
The article was a 12-page review paper ready to be presented at an forthcoming conference. Healy's name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes.

The company replied, saying he had missed some 'commercially important' points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form - under another doctor's name.

Healy says such deception is becoming more frequent. 'I believe 50 per cent of articles on drugs in the major medical journals are not written in a way that the average person would expect them to be... the evidence I have seen would suggest there are grounds to think a significant proportion of the articles in journals such as the New England Journal of Medicine, the British Medical Journal and the Lancet may be written with help from medical writing agencies,' he said. 'They are no more than infomercials paid for by drug firms.'

In the United States a legal case brought against drug firm Pfizer turned up internal company documents showing that it employed a New York medical writing agency. One document analyses articles about the anti-depressant Zoloft. Some
of the articles lacked only one thing: a doctor's name. In the margin the agency had put the initials TBD, which Healy assumes means 'to be determined'.

Dr Richard Smith, editor of the British Journal of Medicine, admitted ghostwriting was a 'very big problem' .

'We are being hoodwinked by the drug companies. The articles come in with doctors' names on them and we often find some of them have little or no idea about what they have written,' he said.


Source: http://www.guardian.co.uk/medicine/stor ... 06,00.html


http://www.infoshop.org/inews/stories.p ... 10/7671896
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Offline Deborah

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FDA warning on SSRIs
« Reply #96 on: December 12, 2003, 09:42:00 PM »
For what it's worth.....
If you took SSRIs as a youth and are interested in testifying before the FDA this Feb. in DC.
Interest in this issue is really building, now that the British have banned SSRIs for
youth. Info on how to get the guidelines
on how to testify, etc. below.
**********

The FDA has scheduled a hearing on Feb. 2, 2004, of the Psychopharmacologic Drugs Advisory committee and the Pediatric Subcommittee of the
Anti-Infective Drugs Advisory Committee.
In order to testify at that hearing on the
adverse effects of antidepressants upon children and teens you must contact Anuja Patel at
301-827-6790 or e-mail her at [email protected]
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Hidden Lake Academy, after operating 12 years unlicensed will now be monitored by the state. Access information on the Federal Class Action lawsuit against HLA here: http://www.fornits.com/wwf/viewtopic.php?t=17700

Offline Deborah

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« Reply #97 on: June 05, 2004, 08:35:00 PM »
June 3, 2004
New York State Official Sues Drug Maker Over Test Data
By GARDINER HARRIS

In a novel claim testing the way that the $400 billion worldwide pharmaceutical industry is regulated, the New York State attorney general, Eliot Spitzer, sued the British-based drug giant GlaxoSmithKline yesterday, accusing the company of fraud in concealing negative information about its popular antidepressant medicine Paxil.

The civil lawsuit, filed in State Supreme Court in Manhattan, contends that GlaxoSmithKline engaged in persistent fraud by failing to tell doctors that some studies of Paxil showed that the drug did not work in adolescents and might even lead to suicidal thoughts. Far from warning doctors, the suit contends, the company encouraged them to prescribe the drug for youngsters.

"The point of the lawsuit is to ensure that there is complete information to doctors for making decisions in prescribing," Mr. Spitzer said in an interview. "The record with Paxil, we believe, is a powerful one that shows that GSK was making selective disclosures and was not giving doctors the entirety of the evidence."

GlaxoSmithKline officials issued a statement yesterday saying in part that the company "has acted responsibly in conducting clinical studies in pediatric patients and disseminating data from those studies."

On Wall Street yesterday, the American depository receipts of GlaxoSmithKline fell $1.38, or 3.2 percent, to $41.39.

Mr. Spitzer filed his suit at a time that the tendency of many drug companies to publicize only studies with positive results has come under increasing criticism.

As he has done in actions involving the financial services and mutual fund industries, Mr. Spitzer is entering regulatory terrain that has been largely the preserve of the federal government, in this case the Food and Drug Administration. This time, though, he maintains that his suit is not a criticism of federal drug regulators.

"This isn't Harvey Pitt and the S.E.C.," he said, referring to the former chief of the Securities and Exchange Commission, whom Mr. Spitzer criticized as less than vigorous in enforcing federal securities laws. Instead, Mr. Spitzer said that the F.D.A. had been hamstrung by court rulings that have used free-speech arguments to limit the agency's power to regulate what drug companies can say to doctors. Such rulings do not limit his powers, Mr. Spitzer said.

"You cannot invoke free-speech arguments as a defense to fraud," he added.

Similar suits against other drug companies are likely, Mr. Spitzer said. "This is an area that we're interested in," he said, "and I think there are other cases out there that are analogous."

A spokeswoman for the F.D.A. would not comment on the lawsuit but noted that the agency required companies to submit all data related to the safety of their drugs. Because so much drug company data submitted is considered proprietary, it is up to the F.D.A. to decide when to disclose possible public safety concerns.

That is what it did last year, when it warned doctors on the use of Paxil for adolescents and children. Earlier this year, it required antidepressant makers to strengthen suicide warnings on labels.

British drug regulators have banned the use of all but Prozac for the treatment of depression in adolescents and children. Prozac, made by Eli Lilly & Company, received a major American endorsement this week when the widely anticipated results of a study sponsored by the National Institute of Mental Health indicated that Prozac was superior to talk therapy alone or a placebo in treating depression among teenagers. The study did not address suicide risks.

Civil suits have been filed against Glaxo and some other makers of antidepressants by patients or surviving relatives, contending that the drugs caused violent or suicidal behavior. Some criminal defendants have contended that violent acts were a result of using the drugs.

Mr. Spitzer's lawsuit is part of a broad assault by prosecutors on the drug industry's marketing practices. Last month, for example, federal prosecutors in Boston announced a settlement with the world's largest drug maker, Pfizer; the company agreed to pay $430 million and to plead guilty to charges that its Warner-Lambert unit promoted the drug Neurontin to doctors for the treatment of conditions where no benefit had been proved.

TAP Pharmaceuticals agreed to pay $800 million for inappropriate marketing practices, and its former executives are facing federal criminal charges in Boston. Schering-Plough has acknowledged in regulatory filings that it is likely to be indicted for improper marketing practices. Other companies are being investigated.

At issue in most of these investigations, including Mr. Spitzer's Paxil suit, is the marketing of approved drugs for off-label uses - those not specifically approved by the F.D.A. While doctors are free to prescribe an approved drug for any use, the manufacturers are supposed to limit their marketing to those uses with F.D.A. clearance.

The new wrinkle in Mr. Spitzer's suit is his argument that a drug maker is committing fraud if it does not tell doctors about trials of a medication that raise safety concerns.

"I'm certainly not the person to determine whether Paxil is appropriate or not for any given patient," Mr. Spitzer acknowledged. "But what I can do is ensure the information to doctors is fair and complete so that those equipped to make this determination can do so."

Dr. Barry Perlman, president of the New York State Psychiatric Association, said in an interview that his organization supported a crackdown on the failure to disclose negative information on drugs.

"Whenever we don't have the complete picture," he said, "we can't prescribe ethically and appropriately, and that's an enormous obstacle to good care."

Richard Merrill, a University of Virginia law professor and a former general counsel at the F.D.A, compared Mr. Spitzer's suit to product-liability lawsuits by individuals. He said the suit was the first by a public official against the drug industry.

Pharmaceutical companies sponsor most clinical trials of drugs and, in many cases, they jealously guard the data that results. If a test suggests that a drug is effective in treating a certain condition, the company will push to get its results published in a prestigious journal. If the results reflect poorly on the drug, they often never appear in public.

Experts have long criticized the tendency in the industry to publish only positive clinical trials, arguing that this distorts medical practice and undermines the scientific process. Some have suggested that the results of all clinical trials should be published in a federal registry.

But some say that doctors are unlikely to consult such a registry and will continue to be influenced by trial results published in leading journals.

Mr. Spitzer's suit is the first to suggest a way of resolving such matters. If a company's marketing message is at odds with the results of its own, suppressed clinical trial, he argues, the company is liable for damages under consumer fraud laws.

In the case of Paxil, GlaxoSmithKline sponsored five trials of the drug in adolescents suffering from major depression. The company undertook the trials to qualify for a six-month extension of Paxil's patent granted under a federal law that encourages the testing of drugs in children. But it published only one of the trials, which showed mixed effect. The unpublished trials failed to show any benefit for the drug and suggested that it might increase the risk of suicide.

An internal memo cited in the suit said the company should have "effectively managed the dissemination of these data in order to minimize any potential negative commercial impact."

And, according to the suit, the company told its sales representatives that "Paxil demonstrates remarkable efficacy and safety in the treatment of adolescent depression." The suit contends that sales representatives passed this on to doctors.

The company's statement yesterday said the memo, written in 1998 - before the merger of SmithKline Beecham and Glaxo Wellcome of Britain that created the current company - "is inconsistent with the facts and does not reflect the company position."
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Offline Deborah

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« Reply #98 on: June 06, 2004, 11:04:00 PM »
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Offline Deborah

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« Reply #99 on: June 07, 2004, 11:03:00 PM »
Green Party Canada is on the right track
The US should be ashamed.

http://www.greenparty.ca/platform2004/e ... .php?p=169

The Green Party supports mental health practices that are humane, empowering and voluntary.

The Green Party will:

Safeguard human dignity and human rights, respecting individual autonomy and protecting informed consent.
Recognize that social- and recovery-oriented models of care make the best scientific and economic sense.
Recognize that involuntary procedures are incompatible with the principle of self-determination.
Limit the use of any surgical, manipulative and electromagnetic disruptions that are found by the Health Protection Branch to be harmful to the health of Canadians.

The Green Party will:
Work with the provinces to create a National Mental Health Network that supports self-help groups, social service agencies, independent living centres and advocacy projects.
Research the effectiveness and safety of using long term pharmaceutical treatments for the mental and emotional health problems of children and adults.
Create new physician guidelines to limit the prescription of antidepressants and behavior-altering pharmaceuticals for children.
Involve mental health clients and psychiatric survivors in research planning, policy development, program evaluation and other decisions that affect their lives.
Increase research into the effectiveness of treatment alternatives, including community-based support programs, peer support, counseling, nutritional, herbal and traditional medicine practices ? such as yoga, massage and acupuncture.
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Offline Anonymous

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« Reply #100 on: June 08, 2004, 07:07:00 AM »
Um, I read yesterday in the news that the British have *not* banned SSRIs in youth.

They allow Prozac, based on recent studies showing it is safe and effective in pediatric cases of depression.

My understanding is that the British are concerned about off-label uses without (real, non-ghost-written) supporting research.

As they should be.

Just because some people try to pull a fast one with research that isn't, doesn't mean that genuine, replicable research that actually does follow the methods of good science can or should be ignored.

Also, many of these illnesses are genetic, and there is a touchstone that many psychiatrists have noticed for predicting adverse reactions or good responses.  If a same sex close relative does well on a medication, that is a very solid indicator that the patient will do well on that medication.

They aren't flying nearly as blind as your articles would make it sound.

People with moderate problems that aren't having serious adverse life consequences probably should be very cautious about taking psychotropic medication.

For those of us with major mental illnesses that are heavily genetic, the balance of risks and stakes are different.

Timoclea
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Offline Deborah

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« Reply #101 on: June 08, 2004, 12:03:00 PM »
Timoclea,
We have opposing views on this issue and it would be futile to debate.
I would only ask you to post the proof that ANY 'mental illness' is genetic. If you can't, then it would seem more appropriate/accurate to say that certain 'mental illnesses' are ASSUMED to be genetic; rather than to make a declarative statement- Another problem with scientist and researchers, they present their assumptions as if they were the truth. Run a biased 'study' and present their 'results' as fact.
There's a good article below that gives insight into the British attitude, which is contrary to what you suggested, and compares and contrasts the US and Britian. The latter much more conservative. You think the US has more people with genetic defects? Or more profit-driven greedy people offering the latest and greatest quick fix?
As my friend said the other day, "Maybe the fascist establishment wants children to be quiet and docile. The government might want to pathologize people with certain temperaments."

That may seem far-fetched to you since you are learned in the school of psychiatry, but many see this outrageous drugging of our children as a form of eugenics. Have you stopped to contemplate what our culture will look like in 20-40 years? Matrixville. Will the children in future generations be able to produce their own brain chemicals, or be dependent on a pill, because their parents and their parents took SSRIs and the ability to produce brain chemicals was 'bred' out of them. What might that be like? You do know that continued use will inhibit the body's ability to produce? It creates dependence.

When I address this issue, I am not attacking your choice to take psych drugs. I will not sit back and listen to anyone suggest that 'mental illnesses' are genetic and a pill will fix them, when there is NO scientific data to PROVE either.

http://society.guardian.co.uk/mentalhea ... 22,00.html
Drugs for depressed children banned
The exception is Prozac, which is licensed for use in depressed children in the US. But the MHRA will warn that, at best, it helps only one child in 10.

Excellent database of related articles:
http://www.benzo.org.uk/ads.htm

http://www.dallasnews.com/sharedcontent ... 04dnnatsea
tbelt.4be39.html
A 49 percent rise in the use of attention deficit/hyperactivity disorder drugs by children younger than 5 in the last three years contributed to a 23 percent increase in usage for all children.
"Behavioral medicines have eclipsed the other categories this year," said Dr. Robert Epstein, Medco's chief medical officer. Antibiotics still top the list of the most commonly used children's drugs, but parents are paying more for
behavioral drugs, such as stimulants or antidepressants, according to the analysis of drug use among 300,000 children.
The most startling change was a 369 percent increase in spending on attention deficit drugs for children younger than 5.
But the use of other behavioral drugs also jumped in the last three years. Antidepressant use rose 21 percent, and drugs for autism and behavior disorders jumped 71 percent, compared to a 4.3 percent rise in antibiotics.

http://www.denverpost.com/Stories/0,141 ... 61,00.html
http://www.ahrp.org
Under the guise of "screening for depression," a High School-based clinic in Denver operates much like a drug dispensing outpost for SSRI drug
manufacturers at taxpayer expense. The Denver Post reports that students who come in for a physical check up are "screened" for depression by use of a suggestive questionnaire. The  students invariably leave the clinic with an
antidepressant drug prescription:
"One benefit is that the program offers students one-stop shopping. They can be diagnosed and treated and, in some cases, even prescribed antidepressants without leaving school."

http://www.philly.com/mld/philly/living ... 799.htm?1c
The use of antidepressants among children grew three- to tenfold between 1987 and 1996, data from various studies indicate, and a newer survey found a further 50 percent rise in prescriptions between 1998 and 2002. The explosion in antidepressant use occurred even though the vast majority of clinical trials
have failed to prove that the medicines help depressed children.
The spike in prescriptions over the last five years has been especially sharp among children younger than 6, even though there is virtually no clinical trial data on these youngest patients.

http://www.canada.com/edmonton/edmonton ... 9bd2-7faf-
4bff-9214-b935936948ed
Children who took a placebo showed strong improvement and those who took the real drugs didn't do significantly better. Two small studies found no advantage for the antidepressants over the placebo.
None of the drugs has been approved in Canada for anyone under 18, but doctors are prescribing them "off-label" -- which they are allowed to do -- to children as young as three for depression, anxiety, social phobia, attention problems and obsessive-compulsive disorder.

http://www.motherjones.com/news/feature ... rders.html
Disorders Made to Order
Word of the hidden epidemic began spreading in the spring of 2001. Local newscasts around the country reported that as many as 10 million Americans suffered from an unrecognized disease. Viewers were urged to watch for the symptoms: restlessness, fatigue, irritability, muscle tension, nausea, diarrhea, and sweating, among others. Many of the segments featured sound bites from Sonja Burkett, a patient who'd finally received treatment after two years trapped at home by the illness, and from Dr. Jack Gorman, an esteemed psychiatrist at Columbia University. Their testimonials were intercut with peaceful images of a woman playing with a bird, and another woman taking pills.

The timing of the media frenzy was no accident. On April 16, 2001, the U.S. Food and Drug Administration (FDA) had approved the antidepressant Paxil, made by British pharmaceutical giant GlaxoSmithKline, for the treatment of generalized anxiety disorder. But GAD was a little-known ailment; according to a 1989 study, as few as 1.2 percent of the population merited the diagnosis in any given year. If GlaxoSmithKline hoped to capitalize on Paxil's new indication, it would have to raise GAD's profile.


New York Times, May 25, 2004
COMMENTARY
Two Countries, Two Views on Antidepressants
By SALLY SATEL, M.D.
Excerpts:
Where you stand depends on where you sit."
This saying usually applies to political issues, but it is also relevant to medicine. Consider the current controversy over the prescription of
antidepressants to children, and the different reactions of British and American regulators and physicians.

After examining a series of 13 clinical trials including more than 2,300 children and adolescents, drug regulators in Britain strongly urged doctors not to use certain antidepressants, among them Paxil, Luvox and Zoloft, for childhood depression because the risk of self-harm and suicidal thoughts was
judged to be too great.

In the United States, however, officials at the Food and Drug Administration, relying on the same clinical data, have yet to make up their minds on the safety issue, and doctors here continue to prescribe antidepressants to
children in volume.

In Britain, 40,000 patients under 19 years old are taking antidepressants, mostly those in the class known as selective serotonin reuptake inhibitors, or S.S.R.I.'s, according to the Medicines and Healthcare Products Regulatory
Agency. This compares with estimates of one million children and adolescents taking
such medication in this country.

Adjusted for population, that means that American doctors are five times as likely as British doctors to prescribe antidepressants to children. Most British physicians consider psychotherapy, not drugs, to be first-line
treatment for childhood and adolescent depression.

Why the different approaches? Much of the answer lies in contrasting medical cultures. "The British think we overdiagnose and overtreat children," said Dr. David G. Fassler, a child psychiatrist at the University of Vermont College
of Medicine.

Prof. Frank Furedi, a sociologist at the University of Kent in England, agreed. "We are more cautious about medicalizing the problems of children," he said.

The same phenomenon can be seen in the treatment of attention deficit hyperactivity disorder. Despite clear benefits, physicians in Britain were slow to use Ritalin and other stimulants, in part because hyperactivity itself was
considered very rare until well into the 1980's.

Meanwhile, American physicians were diagnosing hyperactivity in children in the late 1960's, and regarded stimulants as standard frontline treatment.

Americans' greater faith in medication in these situations may reflect an enthusiasm about technological progress.

"We in Britain are more skeptical of advances in general," said Dr. David Healy, a psychiatrist at the University of Wales College of Medicine and a critic of antidepressant use in  children. "For example, it took us longer to adopt imaging technology like CAT scans and M.R.I.'s as routine."

Unquestionably, antidepressants have saved countless lives, but they also reinforce the existence of the very disease they are meant to treat. As Dr. Healy argued in his new book, "Let Them Eat Prozac," when drugs are developed for a
specific condition, rather than for a general state like stress, pharmaceutical companies end up marketing mental illnesses, not just pills.

"It is no coincidence," he said, "that an explosive increase in diagnoses of depressive illness followed the development of S.S.R.I.'s."

In the United States, the tendency to sell diagnoses gets an extra boost from direct-to-consumer advertising, which is banned in Britain.

In addition, patients in Britain have less choice among medications than they do in the United States. As Dr. Steven A. Schroeder, a former president of the Robert Wood Johnson Foundation, who once studied medicine in London,
said, "Patients have less power in Britain than they do here."

Britain's National Health Service determines the medications that the government will purchase and that physicians will prescribe. Americans have more autonomy in choosing doctors and in negotiating treatments because they pay, either directly or through insurance.

The British, Dr. Schroeder said, seem to have a more modest sense of entitlement. "There, the population is less demanding of treatment for
behavioral and other problems," he said, "and are less likely to seek help for such things
as" attention deficit disorder, chronic fatigue and impotence.

At the same time, in the United States, managed care, with its strong emphasis on cost-saving, creates its own demands. Pills are cheaper than
psychotherapy, and so they are more popular.

"Initially, managed-care companies promoted psychopharmacology for depressed adults," Dr. Fassler said. "Now there's more pressure to treat children and adolescents with medication. And more and more of the prescribing is being
done by pediatricians as opposed to child and adolescent psychiatrists."

All these factors help explain why British health regulators have a lower tolerance for risk, especially when benefits may be minimal.

Practically no one disputes that antidepressants are only minimally effective in children. Some children appear to be helped enormously - hence the many doctors who swear by these medications - but the studies indicate that on average, the advantage over placebo treatment is small. (The British exempted Prozac from their warnings, because the regulators concluded that there was more evidence for its effectiveness and safety in children).

The important issue, then, is whether antidepressants truly worsen the potential for suicide. The F.D.A. says it does not yet know the answer because in the clinical trials, minor episodes of self-harm and more serious episodes
were lumped together under the umbrella  term "possibly suicide-related event."

No distinction, for example, was made between young patients who took large overdoses of the drugs or who tried to hang themselves, and those who made superficial scratches on their arms. There were no actual suicides in the studies.


The F.D.A. has asked researchers at Columbia to reclassify the cases of self-harm to clarify their nature. In the meantime, the agency has issued strong warnings to doctors to closely monitor patients they are treating with these
medications. This summer, the agency will weigh the potential risks of the drugs against the clinical benefits and presumably reach some conclusion.

In comparison, the British, through their different prism, see little need to pursue the question. Lacking a strong cultural investment in antidepressants, they have already decided that any risk of self-harm is too high.

Sally Satel is a psychiatrist and a resident scholar at the American Enterprise Institute.
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Offline Anonymous

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« Reply #102 on: June 08, 2004, 01:18:00 PM »
There is a link on the TAUSA website to a PBS interview with a leading pediatrics physician who shares his views on this very topic, seemingly in agreement with arguments made by both Timoclea and Deborah.

http://www.teenadvocatesusa.homestead.c ... Ahome.html
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Offline Deborah

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« Reply #103 on: June 16, 2004, 01:07:00 PM »
Was just thinking about the tune "In The Year 2525".
In the year 2525
If man is still alive
If woman can survive they may find

In the year 3535
Ain't gonna need to tell the truth, tell no lies
Everything you think, do, or say
Is in the pill you took today

I think that reality may arrive before 3535. And the scienfic communities experiments with brain chips is really scarey.  :scared:
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Offline Anonymous

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« Reply #104 on: June 16, 2004, 01:56:00 PM »
Deborah, I've read the proof that there is a genetic component to the major mental illnesses, in the form of twin studies.

I don't have any percentage in convincing you, and I've got work to do.  I am not going to go down to the University library and spend hours printing out the twin studies and scanning them in and then spend the bandwidth on my website uploading the studies---which I think *still* wouldn't persuade you because I don't think *any* amount of proof would persuade you that there's a heavy genetic component to major mental illness.

I don't think you would consider twin studies that showed a statistically significant (at the 95% confidence level or better) higher incidence of both identical twins having schizophrenia than both fraternal twins as proof of a genetic component to schizophrenia.

Likewise with the other major mental illnesses.

Most scientists *would* consider that proof.

Since I don't think you would, digging up whatever twin studies are out there on various illnesses, paying for the copies, and scanning it all in and uploading it would take at least several days of my time, considerable money in lunch out and parking fees and copying fees, etc., and would be a total waste of that time and effort.

I'm not going to do it.  I'm not going to spend that time and money trying to convince you against your will of something you obviously have a big personal stake of some sort in disbelieving.

It wouldn't do any good---you'd either not believe  it or find some excuse to blow it off.  At least, the risk of such is high and the costs to me tracking it all down are not trivial.

So I'll just put it this way.  My opinion is in the mainstream among professionals in the field and yours is far outside of it, for whatever that is worth.

I'd encourage other readers to make up their mind based on their own consultations with licensed psychiatrists OR based on looking up the research themselves, rather than believing *either* of us.

Timoclea
(Maybe after I've gotten out from under my current work crunch and have some leisure time I'll make a library run, but I won't have time for months, *minimum*.  And that's not for your sake, it's for the sake of people reading who otherwise might be unknowingly led off into a fringe belief that doesn't match the science and that could do them harm.  And I'm sorry I sound so miffed, but it's rather like being challenged to personally provide proof that the Earth is round rather than flat.)
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