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.

Parents deserve to know what the known risks of psychiatric drugs are

photo  credit

Here in Washington State we have only the newest and most expensive neuroleptic drugs listed as the "first-line" treatment for psychosis and schizophrenia; they are "preferred" drugs according to the Washington State Medicaid program.  This is in no small part due to the advocacy of NAMI Washington, through NAMI National, and on the "expert advice" of psychiatrists who are aware of the results of NIMH drug trials.  The NIMH trials of these drugs for both adults and children concluded that the newer more expensive drugs are not safer or more effective than the older MUCH cheaper drugs---yet they are "preferred."  The preferred status of the neuroleptic drugs called "atypical anti-psychotics" or, second generation anti-psychotics, "SGAs" benefits the pharmaceutical companies and their stockholders; not the taxpayers whose money funds the Medicaid program, and certainly not the patients.

The NIMH clinical trials for these drugs do not in fact support the conclusion that neuroleptic drugs called "Atyical Antipsychotics" are any safer, or more effective than the older much cheaper neuroleptic drugs.  This claim is a ploy used to sell the drugs; having no basis in fact, it is a fraudulent claim.  These drugs are in fact only effective for a minority of people with a diagnosis of schizophrenia; for those who are "effectively treated" the risks are extremely high.  Risks which directly impact both morbidity and mortality include diabetes, heart disease, and obesity.  These are three of the top ten conditions which have caused Medicaid costs to spiral out of control, the conditions that the most Medicaid dollars are expended on. 

Washington State's Attorney General has joined in class action lawsuits which have resulted in payments to Washington State for the off-label marketing of psychiatric drugs; but this has not led to increased public awareness.  It has not lead to appropriate psychiatric drug policies being implemented by the Medicaid program.  The changes that have occurred do not protect the children who are wards of the State of Washington, or the adults who are compelled under Court Order to take neuroleptics.  The deleterious effects are still largely minimized, or ignoreed by those who prescribe the drugs; and the iatrogenic injuries and illnesses are MEDICALLY NEGLECTED as a matter of course.

At the same time the settlements for the off-label marketing were being distributed, NAMI was lobbying the Washington State legislature to strengthen the Involuntary Treatment Laws; ensuring that more and more people will be taking these teratogenic drugs, against their wishes, and to their detriment.  Neuroleptics cause a wide variety of iatrogenic illnesses and will continue to cause Washington State's health care costs to spiral out of control.   One cannot help but wonder why is appropriate and medically necessary follow up rarely provided to psychiatric patients?  And, what effect is this having on increased mortality rates?   

This is an ongoing tragedy around the globe. People are not being informed of the risks involved with treating emotional and behavioral issues with drugs.  Primarily this is because the professionals are not being informed; the drug manufacturers conceal adverse event data from the professionals and the public.  Incredibly it gets worse, the FDA has actually concealed risks and has claimed it had no duty to inform the public about adverse events, even fatalities; because the risks were considered, "trade secrets" of the pharmaceutical industry according to the FDA!   There is no way of knowing the actual numbers of those killed, or disabled, by FDA approved drugs, there is no requirement for  psychiatrists or any medical professional who prescribes drugs to  report suspected side effects or adverse events--not even death.  Only a small minority of the deaths are reported by doctors or medical professionals.   

I want to know why so-called patient and family advocacy groups are not telling the people who come to them for help about this?  Why is there no effort being made by these "mental health advocacy groups" to change these obvious flaws in the drug regulatory safety system?  I suspect these "advocacy groups" are not speaking out about the known dangers of psychiatric drugs due to an obvious, and well documented Conflict of Interest that exists:  It is the Pharmaceutical Industry that is the source of much of their funding, and it is the drug industry who oversees development of educational materials they disseminate to patients and parents, friends and concerned community members wishing to support a person with a psychiatric diagnosis.   

More than anything, I want to know why Washington State's Legislature and the Division of Behavioral Health and Recovery have used biased data and flawed reasoning while allowing people with Conflicts of Interest to drive policy for Washington's publicly funded mental health programs?


Recently a documentary, Dead Wrong: How Psychiatric Drugs Can Kill Your Child was released.  The documentary features several parents who have buried their children. All of  the parents lost children as the direct result of their children being prescribed psychiatric drugs---one child died in her mothers arms--she was eight years old.   Any person who cares about children and believes that people should be told the truth when they seek professional help for emotional and behavioral issues should know:  The serious risks are seldom discussed or even disclosed when people are prescribed psychiatric drugs.  Parents are not told of the risks to their children's health and well being; I know I wasn't.  My son is cognitively and physically impaired, and I was never told it was even possible.  I now know it is common for a patient to experience serious, negative effects and even permanent iatrogenic injury; risks include sudden death.  I now know these risks are directly correlated with dose and length of treatment---No psychiatrist who has 'treated' my son ever told us any of this.

Psychiatric Drug Facts Peter Breggin  AHRP

via ProPublica: Advocacy Groups Take Drug Company Cash--

Often Without Full Disclosure

by Marian Wang
ProPublica, Jan. 13, 2011, 4:14 p.m.

1. We’ve reported extensively on the ties between pharmaceutical companies and the physicians they fund to speak, consult and do research. But doctors aren’t the only ones taking money from drug companies—and they’re not the only stakeholders in the field of health whose public disclosures aren’t complete.

According to a new study in the American Journal of Public Health, not-for-profit health advocacy groups like the American Diabetes Association and the National Alliance on Mental Illness also get money from drug companies in the form of grants that—more often than not—aren’t disclosed by those groups.

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The study examined more than 160 health advocacy organizations that received funding from Eli Lilly in the first half of 2007. (Lilly was the first company to make its grant registry public.) Here’s what the analysis found:

As an aggregate, 25% of HAOs acknowledged Lilly funding anywhere on their Web site. Eighteen percent acknowledged Lilly in their 2007 annual report, 1% acknowledged Lilly on a corporate sponsors page, and 10% acknowledged Lilly as the sponsor of the grant event reported in the [Lilly Grant Registry.]

Health advocacy groups often advocate for research and the approval of new drugs on top of promoting public awareness. According to the study, their reputation as a trusted resource for information on specific diseases and their treatments should prompt “far more detailed” disclosure of their corporate grants and industry relationships.

This report isn’t the first time such ties have been spotlighted.

The National Alliance on Mental Illness, or NAMI, came under similar scrutiny back in 2009 when Sen. Charles Grassley, a top Republican, began making inquiries.

From 2006 to 2008, the group took in nearly $23 million in drug company donations—about three-quarters of its fund-raising. At the time, NAMI’s executive director told The New York Times that “the percentage of money from pharma has been higher than we have wanted it to be” and promised greater disclosures.

Following the revelations about NAMI, Sen. Charles Grassley sent letters to 33 health advocacy groups asking them to disclose details about their financial ties to drug and device makers. He has not released the responses he received from the groups.

Today’s report, however, highlighted continued concerns about the degree to which a group’s funding influences its advocacy and helps boost sales for drug companies making donations. Here’s an example from the report, involving NAMI:

This lack of transparency is disappointing because, either by design or through a convergence of interests, the HAOs in the current study pursued activities that promoted the sale of Lilly products.

In the area of neurosciences, Lilly gave NAMI $450,000 for its Campaign for the Mind of America. NAMI has advocated that cost should not be a consideration when prescribing for patients. ‘‘For the most severely disabled,’’ insisted NAMI, ‘‘effective treatment often means access to the newest medications such as atypical anti- psychotic and anti-depressive agents. . . . Doctors must be allowed to utilize the latest breakthrough in medical science . . . without bureaucratic restrictions to the access for life-saving medications.’’To the degree that NAMI’s campaign succeeded, the market for Lilly’s neuroscience drugs expanded.

As we’ve noted, the health care law contains a provision requiring greater disclosure of drug company payments to physicians by 2013, but it does not include company payments to health advocacy organizations.  here

15 Dirty Big Pharma Tricks from Alternet

Videos

The Watch List: The medication of foster children

January 7, 2011

Nearly one in every 10 American children is diagnosed with a mental health disorder. Often the treatment prescribed is medication, and often the medication is heavy-duty — so-called antipsychotic drugs.

In this report, you’ll see that foster care children are prescribed drugs at a rate much greater than that of other kids. Concern over their well-being — not to mention the amount it costs to treat them — has prompted the Government Accountability Office to investigate potentially abusive prescribing practices in America’s state foster care systems. The GAO findings are expected to come out later this year.

Need to Know correspondent Shoshana Guy went to Texas to investigate overuse of psychotropic drugs in foster children, as well as that state’s efforts at reform.

Watch Fri., Jan. 7, 2011 on PBS. See more from Need To Know.

                        

Series of 5 10 minute videos of Mother Telling What Happened To Her Son

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