Three GSK clinical trials failed to demonstrate Paxil's effectiveness for treating depression in children

via 

Hooked: Ethics, Medicine, and Pharma:

Inside Paxil Study 329, Courtesy the Justice Department 

July 3, 2012

a couple of excerpts:

"Thanks to the U.S. Justice Dept. complaint in the suit recently settled by GlaxoSmithKline for a record $3B:http://www.justice.gov/opa/documents/gsk/us-complaint.pdf
--we can follow the history of this study in more detail, based on the internal GSK documents discovered during the proceedings, and see just how the data were manipulated for marketing purposes."

"More important, the 11 patients with serious adverse reactions due to Paxil, and the 5 of them with specifically suicidal or agitated symptoms, magically disappeared. In the revised manuscript the investigators suddenly decided that only one of the reactions (headache) was actually caused by Paxil, and the other bad outcomes were unrelated to the drug. When the FDA got its hands on the raw data from 329, it eventually determined that 10 of 93 patients taking Paxil had experienced a potentially suicidal reaction--a far different and scarier picture than that portrayed in any of the drafts or in the final manuscript." read here

via Pharmalot:

Brown University, A Paxil Study And Retractions
By Ed Silverman // February 6th, 2012 // 10:52 am

a couple excerpts:

"The Department of Health & Human Services, by the way, was also reluctant to pursue the matter. In a letter last November to Jureidini, John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity at the HHS, noted that Paxil effectiveness was “apparently exaggerated.” But he went on to say that his office was unable to pursue an investigation due to the statute of limitations."

"Due to the statute, “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct… Further, given the significant lapse of time between the time the study was conducted and concerns raised, the likelihood of being able to conduct a fair and objective review, given the inevitable difficulties in locating records and relying on memories of events well over 10 years ago, seems remote” (here is the letter). Say Jureidini: “We are a bit stuck about where to take it from here.” read here

Thank you Evelyn Pringle for listing all the dirty dogs who put their names on Study 329: 

"Give credit where credit is due. In alphabetical order, the full list of authors who signed on to the ghostwritten and fraudulent Paxil Study 329 includes: Boris Birmaher, Gabrielle Carlson, Gregory Clarke, Graham Emslie, David Feinberg, Barbara Geller, Owen Hagino, Martin Keller, Rachel Klein, Harold Koplewicz, Vivek Kusumakar, Stan Kutcher, James McCafferty, Rosemary Oakes, George Papatheodorou, Neil Ryan,, William Sack, Michael Strober, Michael Sweeney, Karen Wagner, Elizabeth Weller, Nancy Winters"

I wonder, if John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity has any idea what integrity is. Or if he is aware there are no limits to how many will be harmed or killed because of people who have been promoted to a position that is above their level of incompetence. 

People were not warned of the risks, children and adults have died and have killed others, babies have been born with serious defects and many have died soon after they were born; all for the love of money.  That these horrible things have happened as a direct result of the failures of people who work for the American people; or more accurately, collect a paycheck that is funded by the American people.  In reality, public servants have performed their jobs as if their primary duty was to ensure that marketing campaigns, illegal marketing included, are extremely profitable.  The means being unethical, illegal or deadly was of no consequence, as long as the ends were attained. 

Every one of the doctors named above knew of the risks, it is safe to assume they did not care that people would die because of their subterfuge. They received their paychecks for aiding and abetting a massive fraud that was perpetrated on vulnerable people; a fraud that has caused the deaths of patients; were uninformed so unaware of the risks they faced. The fraud was enormously profitable, in no small part due to the ongoing efforts of psychiatrists who are members of the American Academy of Child and Adolescent Psychiatry, and the American Psychiatric Association; and the cooperation of public servants who work at the FDA, Health and Human Services, and the Centers for Medicare and Medicaid without these public servants' cooperation and abdication of their ethical duty the fraud could not have been perpetrated so successfully, nor could it continue unabated as it has. 

Unfortunately, so do the drug-induced homicides and suicides...  

Paxil gif: jeaniejinx photobucket

Study 329 and the fraudulent FDA approval of Paxil for pediatric use

via CrookReport

via Project on Government Oversight

Warning to readers: hold your nose. Study 329 really stinks.

If you’re new to the issue, corporate funded ghostwriting involves a pharmaceutical company that hires a PR firm to write medical studies. The PR firm then presents the manuscript to academic physicians to sign their names on as authors. Sometimes, the authors make only minor changes. The professors get credit for a publication to add to their CVs, and the pharma company gets a study that is "authored" by physicians who are leading researchers in their field and appear to be independent.

The practice of ghostwriting drives up the costs of healthcare, because these studies trick doctors into prescribing drugs that may be more costly, and sometimes less safe. These studies can also be used to seek approval by the FDA and payment from federal healthcare programs.

In the case of Study 329, GlaxoSmithKline used the study as a tool to market Paxil for use on children, until both the FDA and its British counterpart warned doctors to stop prescribing Paxil to children because it could cause them to commit suicide.

Last November, POGO sent a letter to National Institutes of Health (NIH) asking why taxpayers were funding researchers involved in Study 329 when it was ghostwritten and flawed.

Anyways, the retracted article in The Coast detailed some of Study 329's problems and quoted Alison Bass, a former medical writer at The Boston Globe. Ms. Bass wrote an extensively referenced book titled Side Effects on the scandals and corruption involved in Study 329. The book was widely reviewed by media such as The New York Review of Books and The Canadian Medical Association Journal.

But her book isn't the only detailed account of ethically questionable behavior in Study 329.

In January 2007, the BBC ran an investigative report on Study 329, calling it "one of the biggest medical scandals of recent times." Thttp://www.cmaj.ca/cgi/content/full/179/12/1309he BBC released several internal company documents purporting that GlaxoSmithKline knew that Study 329 was flawed years before the results were published. The BBC also quoted Fiona Godlee, editor of the British Medical Journal, who called Study 329 a "problem" in scientific research.

The list of studies and experts critiquing Study 329 goes on and on.

I vote for Paxil!

So with such an extensive public record on corruption in Study 329 (just use Google, for goodness sake!) how did Dr. Kutcher characterize Study 329?

"I don't think that study caused any particular controversy," he said. "There certainly is a group of people who would like to cause a controversy around it, but science is nasty, brutish and long."

Nasty and brutish? No doubt. Especially, when all those documents and reports on Study 329 are splashed across the Internet.

Still, The Coast apparently ran afoul of Canadian law by publishing a negative story so close to the time of an election. After The Coast retracted and apologized, Dr. Kutcher dashed off a press release.

"It comes as a great surprise that The Coast is confusing opinion with science," he wrote. Dr. Kutcher then crowed, "[T]his is something we are more accustomed to hear from the American right wing than the Canadian left wing."

Yep. Right. Uh-huh.

Intrigued, I called the contact person listed at the bottom of the press release, Layton Dorey. When I asked if he had looked into the problems with Study 329, he said that I should contact Dr. Kutcher at his university.

"Did you see the BBC documentary on Study 329?" I asked.

Long pause…more pause…finally… "I'm not in a position to discuss that," Mr. Layton said.

We then agreed that I would email him questions. He never responded.

I also sent questions to Dr. Kutcher. I then called to confirm that he had received them.

Yesterday morning, Dr. Kutcher's attorney sent a terse email, writing that Dr. Kutcher would not be commenting further on The Coast article. I extended another offer for Dr. Kutcher to respond to questions about Study 329.

Nothing.

For the edification of readers, Canadian voters, and parents whose children were prescribed Paxil, we have provided those questions below. Feel free to provide any answers you feel are pertinent in the comment section of POGO's blog.


Questions for Stan Kutcher regarding press release and Study 329

Dr. Kutcher,

I need to ask you some questions regarding the press release on Tom Bosquet's [sic] article and the comments by author and former Boston Globe medical reporter, Alison Bass. I am an investigator at the Project On Government Oversight (POGO) in Washington. I'm working on a deadline for this, so I need your responses by tomorrow 5 p.m. EST.

In case this is the wrong email, or if you are out of town, I am copying the head of your department to ensure you get them before the deadline.

1. In the press release, you note that Alison Bass is "a writer who is among those most frequently cited by the Citizens Commission on Human Rights." What exactly are you implying with this statement?

2. Do you have any information that Alison Bass is a Scientologist and/or is a supporter of Scientology's public campaign against the field of psychiatry?

3. Alison Bass wrote a book alleging corruption in Study 329 titled Side Effects. The book received positive reviews in, among other places, The New Journal of Medicine, The New York Review of Books, The Boston Globe, and the Canadian Medical Association Journal. Were there errors in this book, and if so, could you please explain?

3. Your press release also states: "Dr. Kutcher intends to launch a defamation suit against the publication as a result of its inflammatory innuendo and the potential to damage his personal, professional and political reputation." Does you plan a defamation lawsuit against Alison Bass for the book Side Effects?

4. In January 2007, the BBC ran an investigative report on Study 329, calling it "one of the biggest medical scandals of recent times." Do you feel that the BBC, like The Coast, is guilty of "inflammatory innuendo"? If not, why not? Please be as expansive as you wish, in your response.

5. Dr. Fiona Godlee, editor of the British Medical Journal, told the BBC that Study 329 is an example of a "problem" in scientific research. "[W]e have to work very hard not only to uncover cases such as this but to work out how to prevent things like this happening in the future," she said. How do you respond to Dr. Godlee's charges against your study?

6. Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, lecturer in philosophy at California State University Northridge, published a study in 2008 that examined Study 329 and charged that the authors selectively reported results that favored GlaxoSmithKline. They have called for Study 329 to be retracted. How do you respond to their charges?

7. Drs. Jeffrey Lacasse and Jonathan Leo published a study in PLOS Medicine last year charging that Study 329 was ghostwritten by a company paid by GlaxoSmithKline and misrepresented data. How do you respond to their charges and do you plan to write a letter to PLOS Medicine to set the record straight?

8. Last November, POGO sent a letter to the National Institutes of Health charging that Study 329 was ghostwritten and "clearly flawed." We attached several document to our letter to support the claims of ghostwriting. Do you have documents to counter our claims? If so, will you make them part of the public record?

9. Are you required to disclose your financial conflicts to your university as is required here in the United States? If so, what was your financial relationship with GlaxoSmithKline at the time of Study 329's publication? How much money have you received from pharmaceutical companies in the last two years?

10. Within two years of Study 329's publication that found efficacy for Paxil in adolescents, the United Kingdom government warned British physicians to not prescribe Paxil for children due to fears of potential suicide. In May 2004, our own FDA issued a similar warning. Why do you think these two regulatory bodies came to dramatically different conclusions from your own published research?

Thank you so much for your time. I really appreciate it. Again, I need a response to our questions by tomorrow at 5 pm EST. If you have any other questions, please feel free to give me a call.

Sincerely,

Paul

UPDATE: Ed Silverman over at Pharmalot got a response from Stan Kutcher's chairman, Nicholas Delva. Dr. Delva toldPharmalot, "I have no concerns about Dr. Kutcher or his participation in Trial 329, and we will, therefore, not be conducting any investigation of his participation in this study."

I'm a little nonplussed by this response. Three years ago, a couple of reporters at Brown University did some digging and found plenty of concerns about the study. As I told Pharmalot, "It's pretty pathetic that a couple of college students can figure out the problems with the study, but Dr. Delva still remains confused."

For goodness, sake. The only thing Dr. Delva needs to do for an investigation is search the internet. Doesn't the man know how to use Google?

Paul Thacker is a POGO Investigator.

SSRI Antidepressants: Marketing Mayhem and Madness

The story of the SSRI antidepressants is one of fraud, corruption and greed.  It is not a unique or uncommon story; it is enormously tragic, nonetheless.

If depression is due to a 'chemical' or neurotransmitter imbalance; it is an imbalance that has yet to be identified.  The claim that antidepressants are fixing an identified imbalance was developed as a marketing strategy.  The strategy is based not on an identified or defined imbalance; it is a hypothesis based on what is understood about the biological mechanism of action of the SSRI antidepressant drugs.  While researchers may one day discover a biological mechanism causing depression, they have not yet actually done so.  This being the case, it is not honest to imply that a 'chemical imbalance' causes depression--it is unethical to use what is essentially a false claim as a marketing tool; in truth using a false claim to encourage "treatment compliance" or to convince a person that they have a disease the must be treated with psychotropic drugs it not ethical, it is criminal fraud. It is morally reprehensible for a professional or trusted patient advocacy organization to imply a hypothesis is a fact.  To claim that depression is caused by an imbalance that psychiatric drugs "safely and effectively" treat without warning patients and parents of children about the well known, inherent risks of taking teratogenic drugs that can cause an episodic condition to become chronic; physical dependency; aggressive, violent behavior; and suicidal and/or homicidal behavior is unethical and morally reprehensible.  How could any medical professional believe that a patient has given Informed Consent for a recommended treatment if serious inherent risks are not disclosed and understood prior to taking a prescribed SSRI antidepressant?   How could any advocacy group fail to warn patients about well-documented risks and the corporate dishonesty which allowed pharmaceutical companies to bury the evidence along with the bodies of those who died due to an adverse reaction to a drug?

The Consumer Protection Act does not apply to the direct-to-consumer marketing of drugs, and the FDA is failing to protect consumers.  Indeed, the FDA consistently protects the pharmaceutical industry, not the American people.  It is FDA policy to consider known negative effects discovered in clinical trials before FDA approval of a drug, including death; 'trade secrets.'  Prescribers are not even legally required to report adverse events for drugs they prescribe to the Adverse Event Reporting System; not even death.  I have spent hours researching on this database, and what is  striking is that most of the deaths are reported by someone other that a doctor, or medical professional with prescribing privileges.

Glaxo Smith Kline the makers of Seroxat, known as Paxil here in the United States, covered up the fact that their drug causes violence, aggression, suicidal and homicidal behavior.   Covered up that it causes birth defects, some so severe the babies die shortly after being born.  Paxil has caused people to have horrific extended withdrawal symptoms, and some people can not in fact seem to stop taking it; no matter how badly they want to. The professionals call it 'discontinuation syndrome,' instead of withdrawal; this is a ploy to disassociate the withdrawal from the fact the drug causes dependency; i.e. addiction.

In England, SSRIs have been restricted; and are rarely prescribed to people under eighteen years old due to the negative effects; the negative effects are known to be more severe for adolescents and children. 

 

Watch Seroxat in News  |  View More Free Videos Online at Veoh.com 

via BBC ONE: Secrets of the drug trials a few excerpts:

"GSK's biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

"Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329."

"In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK."

"He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates."

"In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.
She also found an email from a public relations executive working for GSK which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results."

R.B., Yakama Nation Tribal Member R.I.P.

R.B. was born in December of 1995 and died January 21, 2011.
A member of the Yakama Nation, R.B. was a 15 year old Yakama Native whose emotional and behavioral issues were identified him as a youth who was a priority to be served by the Yakima Valley Systems of Care Mental Health Transformation project.   It is more than tragic that  he lived the last several months of his life in other communities, among strangers.  He was even placed in a facility out of State for a time.  He should have been right here, in the heart of Washington, were he was born, it is where all children belong, in their home communities, among their kin.

In August of 2010 Children's Administration, as his legal guardian, initiates a Children's Long-term Inpatient application.  It was THREE MONTHS before Yakima County Human Services to authorize proceeding with the CLIP application.  Why Yakima County take three months to have this application authorized? It was obviously not a high priority...

In November 29, 2010 the Greater Columbia Behavioral Health Regional Support Network held a staffing and determines R.B. eligible for a CLIP placement; which only places him on a waiting list. He is then sent to Cypress House in Lynwood, WA clear across the state in Snohomish County in early January. Cypress House staff were contracted by the State of Washington to provide line-of-sight and hearing supervision---at all times. He jumped from an Interstate 5 freeway overpass at approximately 2:30 pm on January 21, 2011. It was hours later that Cypress Hill staff were informed. They were apparently not looking for him; although they were aware he was missing, and of his fragile state.

This young man had been a Ward of the State of Washington since May 1998; when he was three years old and had been in 22 different residential facilities and foster homes.  From June 2009, until his death, he had been in a handful of staffed residential facilities.

When we were created, 

we were given our ground to live on

and from this time these were our rights. 

This is all true. 

We were put here by the Creator.

I was not brought from a foreign country 

and did not come here. 

I was put here by the Creator.

Chief Weninock,  Yakama,  1915