Posted on 05/31/2005 10:53:55 PM PDT by neverdem
When the drug industry came under fire last summer for failing to disclose poor results from studies of antidepressants, major drug makers promised to provide more information about their research on new medicines. But nearly a year later, crucial facts about many clinical trials remain hidden, scientists independent of the companies say.
Within the drug industry, companies are sharply divided about how much information to reveal, both about new studies and completed studies for drugs already being sold. The split is unusual in the industry, where companies generally take similar stands on regulatory issues.
Eli Lilly and some other companies have posted hundreds of trial results on the Web and pledged to disclose all results for all drugs they sell. But other drug makers, including Merck and Pfizer, release less information and are reluctant to add more, citing competitive pressures.
As a result, doctors and patients lack critical information about important drugs, academic researchers say, and the companies can hide negative trial results by refusing to publish studies, or by cherry-picking and highlighting the most favorable data from studies they do publish.
"There are a lot of public statements from drug companies saying that they support the registration of clinical trials or the dissemination of trial results, but the devil is in the details," said Dr. Deborah Zarin, director of clinicaltrials.gov, a Web site financed by the National Institutes of Health that tracks many studies.
Journal editors and academic scientists have pressed big drug makers to release more information about their studies for years. But the calls for more disclosure grew stronger after reports last year that several companies had failed to publish studies that showed their antidepressants worked no better than placebos.
In August, GlaxoSmithKline agreed to pay $2.5 million to settle a suit by Eliot Spitzer, the New...
(Excerpt) Read more at nytimes.com ...
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Great post. Thank you.
Drugs trials have become a total scam. Here are three short extracts from respected sources that make the point.
The link between industry, authors and their results
By Jeremy Laurance
23 April 2004
Cancer drugs: Just 5 per cent of studies funded by the pharmaceutical industry reached unfavourable conclusions about the companies' drugs compared with 38 per cent paid for by non-profit organisations. ( Journal of the American Medical Association , 1999)
http://news.independent.co.uk/uk/health_medical/story.jsp?story=514316
Drug firms profit from 'murky' link with journals, study shows Companies are misleading doctors, patients and governments to push their medicines, says a special edition of the 'BMJ' By Maxine Frith, Social Affairs Correspondent
30 May 2003
The "murky" relationships between the world's leading pharmaceutical companies, supposedly independent medical journals and family doctors are exposed in the British Medical Journal today.
http://news.independent.co.uk/uk/health_medical/story.jsp?story=410738
"143 Sudden Deaths Did Not Stop Approval"..
(143 deaths represents MORE deaths then the total of 1999 mortalities in Cororado, Oregon, Idaho, Utah, Washington, New Mexico, Northand South Dakota, Oklahoma, W. Virgina, NJ, Delaware and Alaska combined)
A damning and horrifying accounts of how the US Food and Drug Administration acts in anything but good faith or the public interest. A blistering seven-page expose that points a finger at AIDS activist efforts to speed up the approval process.
"Once a wary watchdog, the Food and Drug Administration set out to become a 'partner' of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal."
By DAVID WILLMAN, Times Staff Writer
WASHINGTON--For most of its history, the United Food and Drug Administration approved new prescription medicines at a grudging pace, daily homage to the physician's creed, "First, do no harm." Then in the early 1990s, the demand for AIDS drugs changed the political climate. Congress told the FDA to
work closely with pharmaceutical firms in getting new medicines to market more swiftly. President Clinton urged FDA leaders to trust industry as "partners, not
adversaries..."
Choice headlines:
"Drug After Drug, Warnings Ignored...danger signs present...even so, top admistrators moved ahead often leaving doctors to assume the risks."
"Warning on Label Omits Deaths...heart problems were mentioned in fine print, not in key dosage data"
"143 Sudden Deaths Did Not Stop Approval...study results kept secret"
"Official Foresaw Deadly Effects..remedy pulled after of death and surgeries"
http://www.latimes.com/news/nation/reports/fda/
Dear Alex,
Drugs will kill you if a disease doesn't do it first. I'll take the drugs.
Such "unbiased reporting". /sarcasm
******
September 27 -- "Killings Were Rare" in Hussein's Iraq?
Alex Berenson misses a major point: "Before the fall of Saddam Hussein's government….Killings were rare, and gun violence rarer still, a testament to the monopoly that Mr. Hussein held on the use of force." What of Saddam's prisons and mass graves?
Glaxco is without doubt the worst (some may say criminal) company in this respect.
Here are just a few of their past actions.
Glaxo Faces Criminal Action In Britain Over 'Suicide' Pills
By Paul Durman and Dominic Rushe
Times Online - UK
6-6-4
GLAXO SMITH KLINE is facing a potential criminal prosecution for allegedly failing to inform British health regulators about the suicide risks associated with Seroxat, its blockbuster anti-depressant. Officials at the Medicines and Healthcare Products Regulatory Agency (MHRA) launched an investigation into Glaxo because of concerns that Britain's biggest pharmaceutical group had withheld important data from clinical trials.
________
On top of that, in reading the results of the study there was NO evidence that Prozac was beneficial unless you call what they found as beneficial: a DOUBLING of the suicide rate and a suicide attempt rate FIVE TIMES GREATER on Prozac than placebo. So, I ask again, where was the evidence of any benefit? And why was none of that reported to the public?
Glaxo Faces Criminal
Action In UK Over
'Suicide' Pills - Paxil
From Dr. Ann Blake Tracy, PhD
_____________
MEMPHIS, Tenn. - The family of a pregnant woman who died while taking an experimental AIDS (news - web sites) drugs to protect her baby from getting the disease is suing the doctors, drug makers and hospitals involved in the study for $10 million.
________
Today's action follows FDA analyses of the post-marketing reports of serious adverse events, which included 5 reports of death in patients taking Lotronex.
Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured
bowels (complications of severe constipation).
www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm.
___________
Drug Company Admits Unsafe Vaccines Were Used
The former UK company Wellcome allowed thousands of babies to be inoculated in the 1960s and 1970s with toxic whooping cough vaccines it knew had not passed crucial safety tests, the Observer, a UK newspaper, claimed on July 8.
_______
Official figures show that Britain's
most heavily polluting factories are still spewing more than 10,000 tonnes of
cancer-causing chemicals every year, Friends
of the Earth claims today.
Nearly half is coming from just one plant, that of Associated Octel which produces lead additives for motor fuel at Ellesmere Port, Merseyside,
the environmental group says. The ICI chemical
plants at Runcorn and Teesside, and Glaxo Wellcome's antibiotics plant at Ulverston, Cumbria, are the next worst offenders, FoE says.
________
GlaxoSmithKline uses animal testing and vivisection in its drug research. In it’s company policy on animal testing GSK “…acknowledges that it has a moral responsibility to ensure best practice in the humane treatment of laboratory animals.”[28] In spite of this, GSK’s testing practices are often cruel, and the tests themselves completely unnecessary.
______
Imitrex, a top-line Glaxo drug, is used by more than two million people worldwide. The drug's sales in fiscal year 1993-94 were $365 million. Both of those numbers are likely to increase when the tablet version of the drug becomes available on the U.S. prescription market this month.
To date, the Food and Drug Administration has received 3,526 voluntary reports of possible side effects, ranging from mild to severe, associated with the use of Imitrex. Included are reports of 83 deaths and at least 273 life-threatening complications.
________
In New York’s Washington Heights is a 4-story brick building called Incarnation Children’s Center (ICC). This former convent houses a revolving stable of children who’ve been removed from their own homes by the Agency for Child Services. These children are black, Hispanic and poor.
Many of their mothers had a history of drug abuse and have died. Once taken into ICC, the children become subjects of drug trials sponsored by NIAID (National Institute of Allergies and Infectious Disease, a division of the NIH), NICHD (the National Institute of Child Health and Human Development) in conjunction with some of the world’s largest pharmaceutical companies – GlaxoSmithKline,
Pfizer, Genentech, Chiron/Biocine and others.
The drugs being given to the children are toxic – they’re
known to cause genetic mutation, organ failure, bone marrow death, bodily deformations, brain damage and fatal skin disorders. If the children refuse the drugs, they’re held down and have them force fed. If the children continue to resist, they’re
taken to Columbia Presbyterian hospital where a surgeon puts a plastic tube through their abdominal wall into their stomachs. From then on, the drugs are
injected directly into their intestines.
In 2003, two children, ages 6 and 12, had debilitating strokes due to drug toxicities. The 6-year-old went blind. They both died shortly after. Another 14-year old died recently. An 8-year-old boy had two plastic surgeries to remove large, fatty, drug-induced lumps from his neck.
This isn't purple journalism, it's ultraviolet.
Can you really dismiss articles from the LA Times, NY Times, FDA, BBC to name but a few, as 'purple journalism?
In every one of the cases I cite above (that involved legal action) Glaxco lost the legal action.
Do you think the American justice system is also 'purple'?
Do you really trust a English drugs multinational more than the American press or legal system?
From you response it seems so.
P.S.
Glaxco does not even pay it's U.S. taxes.
IRS says Glaxo owes $5.2 billion in taxes, interest
The drugmaker said it had paid its U.S. share and would fight the claim over how it apportioned multinational obligations.
By Linda Loyd
Inquirer Staff Writer
GlaxoSmithKline P.L.C. said yesterday that the IRS wanted it to pay $5.2 billion in back taxes and interest on pharmaceutical sales that go back to 1989.
I strike ultraviolet, and say soft X-rays.
Do you also discount the highly respected conservative UK Observer newspaper and Glaxco's own admissions?
There Is No Doubt That Glaxo Is A Problem !
UK Observer July 8, 2001
Drug Company Admits Unsafe Vaccines Were Used
The former UK company Wellcome allowed thousands of babies to be inoculated in the 1960s and 1970s with toxic whooping cough vaccines it knew had not passed crucial safety tests, the Observer, a UK newspaper, claimed on July 8.
It said its investigations showed that two batches of the firm's vaccine were more than 14 times more potent than the standard dose and 14 other batches containing thousands of vaccine doses were not put through a crucial toxicity test.
One of the toxic batches was the same batch that led the Irish Supreme Court in 1992 to award £2.7 million (US$3.8 million) in compensation to Kenneth Best, a Cork boy who suffered permanent brain damage. At the time the Irish judge accused Wellcome of negligence and attacked the company's poor quality control at its Kent laboratory.
Now, 9 years after the award, the newspaper said the Irish Department of Health had received details from GlaxoSmithKline about the batch--numbered 3741--and was tracing 296 Irish children who were inoculated with it.
Glaxo Wellcome merged with SmithKline Beecham to form GlaxoSmithKline in late 2000.
The newspaper added that pressure from Denis Naughten, a senior Irish Member of Parliament (MP), has forced other disclosures from the company, including the fact that a second batch of vaccine, numbered 3732, produced by Wellcome around the same time, was even more potent than that used on Best in 1968.
In the 3 years after Wellcome produced the toxic batches, dozens of British parents believed their children suffered brain damage or even died as a result of the whooping cough vaccine. But their views were dismissed by drug companies and health officials.
The report quotes Gordon Stewart, emeritus professor of public health at Glasgow University, as saying the revelations are "scandalous." Stewart, who in 1984 was asked by the government's Chief Scientific Officer to investigate a link between brain damage and the vaccine, said he advised the Department of Health about these potential toxic batches in 1989 but they did not act.
His report, which was never published by the government but has been seen by The Observer, is highly critical of the whooping cough vaccine used at this time, which he believes was toxic.
Ian Stewart, Labor MP and chair of the all-party Commons committee on the vaccine issue, said he would be holding an emergency meeting of the committee this week and tabling a series of parliamentary questions.
He said, "The families need to know the truth."
"If it can be shown that Glaxo Wellcome were negligent in allowing toxic vaccines to be used, then the company must face up to its responsibilities."
The families of vaccine-injured children receive £100,000 compensation from a government fund financed by the taxpayer. Stewart believes if the firm is at fault, then they should pay compensation, which would be significantly more.
http://www.vaccinationnews.com
So far you have discounted the following sources: -
The LA Times
The BBC
The New York Post
The New York Press
The New York Times
The Observer
The Independent (UK)
Glaxco itself
The FDA
Vaccination News
The IRS
The US Justice System
not bad going....are your a Glaxco stockholder perchance?
Your stuff cherry picks details to appeal to the sensational in the ignorant reader (for example, the kids getting chemotherapy for cancer, which is never stated). You're getting into gamma ray territory, bub.
Sorry.
I forgot: -
The UK Department of Health
The British parliments Commons Committee on the Vaccine Issue
Glasgow University
A senior Irish Member of Parliament
The Irish Supreme Court
Dr. Ann Blake Tracy, PhD
Didn't want to sell you short.
Best wishes,
David
Can you explain what is 'cherry picked' in the article I reprinted in full: - "Drug Company Admits Unsafe Vaccines Were Used ?"
If you check the surces for the other articles you will see that NOTHING is out of context.
Why are you so keen to dismiss this solid factual information?
You have every right to do so but I must wonder why.
"the kids getting chemotherapy for cancer"
Which article claims that?
The ICC story is now the subject of an official enquiry and was even reported by Fox Television not to mention a BBC documentary.
That's the only scenario which would make sense in the ICC story. Chemo drugs are that toxic. Toxicity like that would prevent any other kind of drug from even getting out of the starting gate. And what is this business about tossing in the little details about their mothers being drug abusers? That's an eyegrabber -- speaking eloquently to the purpleness of the prose -- but says nothing about how ethical these trials are. If you're not hiding details then whoever you got this from is hiding them from you.
Dear RedNeck,
The drugs in question were experimental 'AIDS' drugs and the story was run in so many different publications around the World that it cannot be dismissed.
The story has been covered by The New York Press, New York Post, The Observer (UK), Fox Television, Dutch Television, The New York Times and was made into a British Broadcasting Corporation Documentary.
Here are a few facts you can easily check.
The New York City Administration for Children's Services (ACS) has admitted that at least 465 allegedly HIV positive children in foster care were
used to test highly toxic and possibly lethal experimental AIDS drugs during
the1980s and 1990s. ACS Commissioner John Mattingly has stated that the agency has hired an outside research firm (Vera Institute of Justice)
to investigate.
Public hearings took place in New York
The City Council Public Hearings took place on Thursday, May 5, 2005 at10:00 AM, at City Hall, Downtown New York City.
For Information call (718) 398-1766.
FACT SHEET ON ACS ABUSE OF BLACK & LATINO CHILDREN AS GUINEA PIGS
FOR TESTING OF AIDS DRUGS
January 2004: Investigative Reporter Liam Scheff publishes The House that AIDS Built. The article documents ACSTs (NYC Administration for
Childrens Services) use of Black and Latino children in foster care asguinea pigs for trials of toxic AIDS drugs. Drugs were given to children as
young as 1 month old. The article cites deaths of at least four of thechildren at the Incarnation Childrenâ?Ts Center (ICC), the main site of
the testing, which is run by the Catholic Archdiocese of New York. The trials
went on from the mid-1980s through the beginning of this century.
March 2004: Vera Sharav of the Alliance for Human Research Protection
contacts several Federal agencies to get them to investigate and put a halt to ACSs violations of Federal regulations for the protection of
children as research subjects.
March-June, 2004: ACS, in a series of private correspondences in response to
inquiries from City Councilmen deBlasio and Perkins, assures them that ACS
had done nothing wrong. No further inquiry was made or public hearingdemanded by the Councilmen.
December 2004: The December 12th Movement (D12) and Millions for Reparations
(MFR) became aware of the issue through a newly-released BBC documentary,
Guinea Pig Kids, which documented the abuses of ICC. The twoorganizations viewed health care in the Black and Latino communities in general and the human rights violations suffered by the children at ICC, in particular, as an important part of the demand for Reparations. They
immediately launched a multi-faceted campaign to inform the community ofthis issue. It included: weekly demonstrations in front of ICC;
presentationof a letter to the Commissioner of ACS requesting answers to specific
questions on what had occurred at ICC; a letter writing campaign to local,state and federal elected officials demanding that they hold public
hearingson these drug trials.
January 27, 2005: A representative of D12 met with Councilman deBlasio,Chair of the General Welfare Committee, in an unsuccessful attempt to
havehim hold a public hearing on the ICC.
February 8, 2005: In response to D12's December 30th letter to ACSCommissioner Mattingly, ACS called for a meeting. It was held between
representatives of D12, MFR, the Center for Law and Social Justice,
Young,Gifted and Black and a high level delegation of ACS and the NYC Law
Department.
The community representatives left dissatisfied. Many of theirquestions went unanswered, including: i) what were the causes of death ofchildren in the clinical trials; and ii) what were the long-term sideeffects of the drugs used. ACS told them that 76 children had been
involvedin clinical trials and promised to get back to them after they had compiled
the information which had been originally requested in December, 2004.April 22, 2005: ACS, which had still not gotten back to D12 and MFR,announced that it had hired an outside research facility to investigate
them. It also announced that 465 children, not the 76 they told us inFebruary, had been â?oguinea pigs.â?? The actual number may grow.
April 24, 2005: D12 and MFR hold press conference on steps of City Hall,with Councilmen Barron and Perkins, as well as Vera Sharav. CouncilmandeBlasio, through Councilman Barron, announces that he has finally
decided to hold a hearing. MFR, D12 and Parents in Action call for a city-wide demonstration at ICC on April 30th to Shut It Down May 5, 2005 - NYC Council holds Public Hearing on Administration forChildren's Services and the testing of experimental AIDS drugs on
allegedly HIV positive children in foster care.
MILLIONS FOR REPARATIONS: 456 Nostrand Avenue; Brooklyn, NY 11216;
(718)
398-1766 (tel); (718) 623-1855 (fax);
On kids suffering from HIV or AIDS
THE FOX STORY
NYC Must Come Clean on Foster Kids AIDS Scandal
Tuesday, December 07, 2004
By Wendy McElroy
March 03, 2004
Last week, the BBC aired a documentary entitled "Guinea Pig Kids."
It accused New York City’s Administration for Child Services and drug companies, such as Glaxo SmithKline (GKS), of experimenting on HIV-positive foster children with untested and dangerous anti-AIDS drugs.
Two basic accusations were leveled.
First, parents or guardians who refused to consent to the trials claim that children were removed by ACS and placed in foster families or children’s homes. Then, acting over their objections, ACS authorized the drug trials.
The second accusation: the drugs administered to children as young as three-months-old did not demonstrably extend their livespan but did inflict harm and great suffering. Children who resisted were force-fed drugs through a peg-tube inserted into their stomachs.
The charges merit both skepticism and thorough investigation. But, with ACS stonewalling, facts are hard to come by.
Some facts are known.
In the 1990s, experimental anti-AIDS drugs were administered to foster children in ACS custody. In response to the BBC’s accusations, GSK defended those trials by saying that the Food and Drug Administration encourages pediatric testing.
"[C]linical trials involving children and orphans are therefore legal and not unusual," the company said. GSK called the trials "appropriate" as long as they are "in compliance…with the various state and federal laws and regulations regarding legal authority in the case of minors."
The issue of legal authority lies at the heart of the first accusation: namely, that ACS overruled the objections of legal guardians.
The charge first appeared on Feb. 29 in a series of articles written by Douglas Montero for the New York Post. On March 10, FOX News also addressed the potential scandal.
Montero focused on the case Jacklyn Hoerger, as did "Guinea Pig Kids." A pediatric nurse, Hoerger became foster mother to two HIV-positive girls who received treatment at Manhattan’s Incarnation Children's Center. (ICC is one of the sites implicated in the experiments.) Convinced that the "highly toxic" drugs were harmful, not beneficial, Hoerger stopped administering them and pursued alternate treatment. The girls’ health reportedly improved significantly.
Social workers charged Hoerger with child abuse and removed the girls from her custody.
Since Montero’s articles, similar stories have emerged through the BBC and elsewhere. One child, identified only as Garfield, was removed from his grandmother’s care when she stopped giving him drugs that seemed to make him ill. According to the news site Black Britain, Garfield was then placed with a foster mother who "receives $2000 per month to look after him, because she is prepared to give him the medication."
Black Britain hurls the added indictment of racism at ACS because the vast majority of the HIV-positive children are black, like Garfield, or Hispanic.
The second basic charge leveled by the BBC is that the administered drugs harm rather than help the children.
Dr. David Rasnick, an expert on AIDS drugs, offers a heartbreaking description of what the children might suffer.
"We're talking about serious, serious side-effects. These children are going to be absolutely miserable. They're going to have cramps, diarrhoea and their joints are going to swell up. They're going to roll around the ground and you can't touch them." Dr Rasnick called some of the drug combinations "lethal" and further observed, "The young are not completely developed yet. The immune system isn't completely mature until a person's in their teens."
It is difficult for a layperson to evaluate medical claims of harm.
The difficulty is increased by the silence rather than answers offered by ACS, the drug manufacturers and those who conducted the trials.
Advocates such as Michael Weinstein, President of AIDS Healthcare Foundation (the largest AIDS organization in the United States), have called for disclosure. He writes, "These are very serious allegations and we will have to wait to see the facts play out…GSK is being accused of exploiting one of our most vulnerable populations."
In an atmosphere of secrecy, the worst scenarios assume credibility. Vera Sharav, President of the Alliance for Human Research Protection, comments, "there appears to be a policy of giving drug firms access to them [the children]."
If the facts are to "play out" and the worst is not seem credible, then ACS needs to act in an uncharacteristic manner and respond to public concern.
The ACS is one of the most powerful child welfare agencies in North America. The BBC observed, "The ACS, as it is known, was granted far-reaching powers in the 1990s by…Mayor Rudi Giuliani, after a particularly horrific child killing."
An example of that power: the ACS does not require a court order to place HIV children in foster care and on drug trials.
According to family lawyer David Lansner, "They’re essentially out of control. I’ve had many ACS case workers tell me: ‘We’re ACS, we can do whatever we want’ and they usually get away with it."
If the ACS has respected parental and guardian rights, then its files should document the fact. If the ACS has honored laws that require potential benefits to children in medical trials to outweigh risks, then records are the proof.
Power without accountability is an invitation for abuse. Nothing short of transparency will make the hideous accusations raised by "Guinea Pig Kids" go away.
Wendy McElroy is the editor of ifeminists.com and a research fellow for The Independent Institute in Oakland, Calif. She is the author and editor of many books and articles, including the new book, "Liberty for Women: Freedom and Feminism in the 21st Century" (Ivan R. Dee/Independent Institute, 2002). She lives with her husband in Canada.
Respond to the Writer
wendy@ifeminists.net
CC to
_____
I think you will agree this story is shocking but very REAL and the coverage covrs the entire political spectrum. You cannot call Fox Television a liberal source nor dismiss an event subject to public hearings.
I fully understand your disbelief as it seems impossible that such a thing could take place in America.....but it seems that it did.
Warmest regards,
David
views@foxnews.com
Well, fix this in the New Yawk legislature.
"On kids suffering from HIV or AIDS"
Based on 'tests' that we all know are quite useless.
Just read the manufacturers very own small print.
They CLEARLY state they do NOT test for 'HIV' and are only an 'aid to diagnosis'.
To test unproven and highly toxic drugs on orphans based on these non specific tests, is in my opinion, criminal.
"Although a blot POSITIVE for antibodies to HIV-1 indicates infection with the virus..."
"POSITIVE blot results using any specimen type (serum, plasma, or urine) should be followed with additional testing. Such testing may rely on alternative test methods or specimen types.
The clinical implications of antibodies to HIV-1 in an asymptomatic person are not known."
Reveal(TM) Rapid HIV -1 Antibody Test
"The Reveal" Rapid HIV -1 Antibody Test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV -1. This test is suitable for use in multi-test algorithms designed for statistical validation of rapid HIV test results."
http://www.fda.gov/cber/pma/p000023.htm
http://www.fda.gov/cber/pmalabel/P000023LB.pdf
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