Pharma makers withhold suicide data in drug studies

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 Vedantam

Updated: 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 Researchers familiar with the unpublished data said the majority of secret trials show that children taking the medicines did not get any better than children taking dummy pills.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
© 1999 

The 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:

Antidepressants May Trigger Violent Behavior

Psychiatric Drug Use In Toddlers Soars

FDA to hear views on drugs' suicide link

Kids Face Risks Taking Antidepressants

Warning on antidepressants urged

Foregone Conclusions

Drug makers hid bad results
A medical journal accuses Health Canada of complicity by keeping quiet

Sharon Kirkey
CanWest News Service

Tuesday, February 17, 2004

OTTAWA -- Pharmaceutical companies are deceiving patients and doctors by keeping negative results from drug trials "locked in the filing cabinet," Canada's leading medical journal warns.

The Canadian Medical Association Journal says Health Canada is complicit in this "file drawer phenomenon" by too often keeping quiet about buried evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of silencing medical researchers by having them sign agreements that suppress the release of negative findings in drug trials -- sometimes for as long as a decade after the test results are in -- while positive findings are promoted.

Most "negative studies" go unreported because they showed no beneficial effects of the drug being tested. But some hold information that would hurt the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge investment that "puts pressure on companies to suppress results that might slow or extinguish sales," the CMAJ says.

But by burying data, drug companies "deceive physicians, their patients and, perhaps, shareholders. Worse, such concealment is a flagrant abuse of the trust" patients put in doctors when they agree to be test subjects in medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-company sponsored trial unless "drastic" changes are made. Three years ago, Dr. Jane Garland was shown unpublished data that suggested the anti-depressant Paxil was ineffective in children -- but only after she had signed an agreement prohibiting her from sharing the information with other doctors and investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British Columbia's Children's and Women's Hospital, was about to do a study testing Paxil on children with mood disorders when she was sent a confidential "investigator's brochure" that summarized what GlaxoSmithKline knew about its drug.

Buried in the material were results from two studies that showed Paxil was no more effective than a placebo, or sugar pill, in treating depression in children.

At that time, the only study of Paxil in depressed children that had been published suggested a benefit. None of the Paxil-like drugs have been approved in Canada for use in anyone under 18, but they're increasingly being prescribed to children as young as three for depression, obsessive-compulsive disorder, social phobia and anxiety. Doctors can prescribe the drugs "off label," a practice that allows them to prescribe drugs for situations not expressly covered in the approval process.

"My jaw dropped because I already signed a form saying I can't reveal anything I'm about to see," says Garland, whose commentary is one of several articles in today's CMAJ on the burying of clinical evidence.

"I do the continuing medical education (for doctors.) I run the specialty clinic for the province. I teach students and residents and I have to tell them that the medication works based on the one study published, and I'm not allowed to mention that I've seen the other data. It felt terrible."

The evidence came to light last summer, when GlaxoSmithKline warned doctors Paxil shouldn't be given to children because several large trials also found that two to three per cent of children taking the drug developed suicidal thoughts while on the medication, twice as many as children on a placebo.

Last month, Health Canada issued a public advisory about the increased risk of suicide in children for all SSRIs (Selective Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at least since the 1990s. Meanwhile, the number of children prescribed antidepressants in B.C. doubled over the past five years. She estimates 10,000 to 15,000 B.C. children are taking the drugs.

In a written response to a request for an interview, the company said it "began communicating results" from its pediatric studies in 1998 through posters, abstracts and other publications.

"GSK takes very seriously our responsibility to provide health-care professionals the information they need to prescribe medicines. We are devoting significant time and energy to finalize the process of communicating study results so that we have a sound and sustainable policy."

But the problem of hidden drug information is much more widespread, says CMAJ editor Dr. John Hoey.

"It means that physicians who are prescribing these drugs may not have complete information about how good the drug is, does it work or, equally important, how safe is it," Hoey said in an interview.

Drug companies have to make the results of all clinical trials available to Health Canada to get initial approval for a drug, Hoey says. But there is no requirement for the results to be published, or even made available to other researchers.

A Health Canada spokeswoman said that information is owned by the drug company.

Companies are required by law to report serious side effects to the government. But the secrecy in the drug-approvals process and weak systems for monitoring adverse drug reactions are also keeping unsafe medicines on the market, U.K. and Canadian researchers report in today's journal.

Hoey says Health Canada should pressure all drug companies to follow the lead of Merck-Frosst, which plans to publish the results of all clinical trials, regardless of the outcome.