Pharma makers withhold suicide data in drug studies
CategoriesAccording to an article in the Washington Post, the makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.
Apparently the drug makers are free to keep data hidden contravening, if not the letter of the law, the spirit of scientific transparency. Negative findings have a much harder time making it into the public record than those that are "favourable", meaning those that cover up negative effects of the drugs.
"Conflicts of interest and the company control of the data have thrown out the scientific method," said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of trials don't work out, they don't publish them, they don't talk about them."
"We need a journal of negative findings," agrees Darrel Regier, director of the American Psychiatric Association's division of research, who believes the drugs save children's lives. "The probability of those negative findings being published is far less than the chances of positive studies -- even journals are not interested in negative studies."
Of course there are alternatives to the controversial SSRI antidepressants. The currently ongoing Optimum Nutrition for the Mind conference in London is all about using nutritional intervention instead of drugs. It should prove interesting, and I hope to have a further report on it soon. La Leva di Archimede has a delegation attending.
Jon Rappoport of www.nomorefakenews.com made some pertinent comments to the Washington Post story, which I would like to offer here as a little stimulous to start looking....
DON'T WORRY, DON'T WORRY
JANUARY 30, 2004. The excerpts below, from a Washington Post story, involve prescribing SSRI antidepressants to children. Yeah, another scandal. And this one is big, too. I’ve inserted my comments in CAPS between the paragraphs.
Info from clinical trials on children kept secret
By Shankar VedantamUpdated: 12:18 a.m. ET Jan. 29, 2004
Makers of popular antidepressants such as Paxil, Zoloft and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal.
WELL, SURE, HIDE THE DATA. SUICIDES IN CHILDREN? WHO CARES? WE HAVE TO PROTECT THE DRUG COMPANIES. IMAGINE THIS STORY WERE ABOUT TOASTERS. YOU GO TO BUY A TOASTER, AND THE BOX CARRIES A WARNING THAT ALL RELEVANT SAFETY DATA HAS NOT BEEN PUBLISHED BECAUSE THE MANUFACTURER OWNS THAT DATA AND HAS A RIGHT NOT TO RELEASE IT. FINE. THEN YOU HAVE A RIGHT NOT TO BUY THE TOASTER. UNLESS YOU WANT FIRES IN YOUR KITCHEN.
The companies say the studies are trade secrets. Researchers familiar with the unpublished data said the majority of secret trials show that children taking the medicines did not get any better than children taking dummy pills.
THE DUMMY PILLS ARE SUGAR PILLS, PLACEBOS. THE DRUGS DO NO BETTER THAN SUGAR. BUT HEY, IT’S YOUR CHOICE. YOU CAN GIVE A DANGEROUS DRUG TO YOUR KID THAT DOES NO GOOD, OR YOU CAN WAKE UP AND NOT FILL THE DOC’S PRESCRIPTION.
Although the drug industry's practice of suppressing data unfavorable to its products is legal, doctors and advocates say such secrecy distorts the scientific record.
GEE WHIZ, NO KIDDING? THE DRUG COMPANY RUNS 10 CLINICAL TRIALS OF A DRUG AND EIGHT STUDIES SHOW THE DRUG IS INEFFECTIVE, BUT IT ONLY PUBLISHES THE TWO STUDIES THAT SHOW THE DRUG WORKS.
"Conflicts of interest and the company control of the data have thrown out the scientific method," said Vera Hassner Sharav, a critic of the drugs and a patients' rights advocate. "If hundreds of trials don't work out, they don't publish them, they don't talk about them."
NO PROBLEM. YOU HAVE TO HAVE FAITH. GET DOWN ON YOUR KNEES EVERY TIME YOU TAKE THE DRUG---AND PRAY.
"We need a journal of negative findings," agreed Darrel Regier, director of the American Psychiatric Association's division of research, who believes the drugs save children's lives. "The probability of those negative findings being published is far less than the chances of positive studies -- even journals are not interested in negative studies."
THE JOURNALS ARE NOT INTERESTED IN NEGATIVE FINDINGS? I SEE. NEGATIVE ISN’T SEXY ENOUGH. IT’S A WASTE OF SPACE TO PRINT NEGATIVE STUFF. WE ONLY WANT GOOD NEWS. I MEAN, THESE JOURNALS HAVE NOTHING TO DO WITH SCIENCE, SO WHAT DIFFERENCE DOES IT MAKE?
One industry executive, Philip Perera, a medical director at GlaxoSmithKline, said that his preference was to publish all trials but that negative studies could lead doctors to prematurely reject a medicine.
I LOVE IT. IMAGINE SOME CRAZY DOCTOR GETTING THE WRONG IDEA. A NEGATIVE STUDY THAT SHOWS A DRUG DOESN’T WORK MIGHT CAUSE A DOCTOR TO THINK THAT THE RESULTS ARE NEGATIVE. CAN’T HAVE THAT. HE MUST BE SHIELDED FROM THE NEGATIVE. INSTEAD LET’S HAVE POSITIVE STUDIES ONLY. IT’S OKAY IF THE DOC PREMATURELY ASSUMES THE DRUG WORKS.
"If you start publishing negative data, will it be concluded by practitioners and others that the drug is ineffective?" he asked, saying that genuinely effective medicines sometimes do no better than placebos, or dummy pills, in trials -- at least half of all children seem to get better on placebos…”
NOW THIS IS A REVELATION. DRUGS THAT WORK WELL SOMETIMES DO NO BETTER THAN PLACEBOS. WOW. LET’S SEE. YOU RUN A STUDY OF DRUG X. YOU SEE THAT IT’S DOING NO BETTER THAN A SUGAR PILL. BUT STILL, THIS COULD BE A VERY EFFECTIVE DRUG, EVEN THOUGH THE STUDY PROVES IT IS NOT. WHY THE HELL DO THEY USE A CONTROL GROUP AND FEED THEM A SUGAR PILL IN THE FIRST PLACE? BECAUSE IF THE GROUP THAT GETS THE DRUG DOES NOT DO WAY BETTER THAN THE GROUP ON THE SUGAR PILL, YOU CONCLUDE THAT THE DRUG IS USELESS. THAT’S THE WHOLE POINT. THE - WHOLE - POINT. BUT NOW WE HAVE A FANTASTIC ADMISSION/ASSERTION BY A DRUG-COMPANY EXEC. SOMETIMES THE DRUG DOES NO BETTER THAN A SUGAR PILL “BUT IT’S STILL A GOOD DRUG.” WHY NOT JUST SKIP ALL THE STUDIES AND DECIDE IT’S A GREAT DRUG AND SELL IT? CALL IT, OH, DRAINO.
OR WHY NOT JUST ARREST THE DRUG COMPANY CEO AND CHARGE HIM WITH FRAUD AND ENDANGERING CHILDREN AND THROW HIM IN JAIL FOR 20 YEARS? I THINK THIS WOULD BE AN EFFECTIVE DETERRENT. I RAN A STUDY THAT PROVES IT WOULD BE AN EFFECTIVE DETERRENT, BUT I REFUSE TO PUBLISH THE RESULTS BECAUSE THAT DATA IS PROPRIETARY AND I OWN IT.
ALSO, I HAVE COPYRIGHTED A NEW WAY OF DOING CLINICAL TRIALS ON DRUGS. YOU FLIP A COIN. IF HEADS COMES UP, THE DRUG IS GOOD. TAILS, THE DRUG IS BAD. IF TAILS COMES UP, YOU SAY IT WAS HEADS. OF COURSE, YOU CLAIM YOU DID A STUDY WITH 5000 VOLUNTEERS AND THE STUDY COST THE COMPANY 70 MILLION DOLLARS AND THEREFORE YOU HAVE TO CHARGE THE PUBLIC $16 PER PILL.
JON RAPPOPORT www.nomorefakenews.com
Jon also has a very relevant article in the members section of his site. I do highly recommend you sign up and get this and other articles and downloads from his site.An Inquiry into the School Shootings in America
by Jon Rappoport
© 1999The massacre at Columbine High School took place on April 20, 1999. Astonishingly, for eight days after the tragedy, during thousands of hours of prime-time television coverage, virtually no one mentioned the word “drugs.” Then the issue was opened. Eric Harris, one of the shooters at Columbine, was on at least one drug.
The New York Times of April 29, 1999, and other papers reported that Harris was rejected from enlisting in the Marines for medical reasons. A friend of the family told the Times that Harris was being treated by a psychiatrist. And then several sources told the Washington Post that the drug prescribed as treatment was Luvox, manufactured by Solvay.
In two more days, the “drug issue” was gone.
Luvox is of the same class as Prozac and Zoloft and Paxil. They are labeled SSRIs (selective serotonin reuptake inhibitors). They attempt to alleviate depression by changing brain levels of the natural substance serotonin. Luvox has a slightly different chemical configuration from Prozac, Paxil, and Zoloft, and it was approved by the FDA for obsessive-compulsive disorder, although many doctors apparently prescribe it for depression....
See also related:According to an article in the New York Times, "Top officials of the Food and Drug Administration acknowledged for the first time on Monday that antidepressants appeared to lead some children and teenagers to become suicidal."
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.Antidepressants May Trigger Violent Behavior
Psychiatric Drug Use In Toddlers Soars
U.S. Hearing to Explore Antidepressant Risk in Kids
FDA to hear views on drugs' suicide link
Kids Face Risks Taking Antidepressants
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