Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine.
The researchers — Drs. Joseph Biederman, Thomas Spencer and Timothy E. Wilens — are named in the subpoena, which was sent on Wednesday to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines.
The three researchers have advocated increased use of antipsychotic medicines in children and have accepted lucrative consulting agreements from the drugs’ makers. Senator Charles E. Grassley, an Iowa Republican investigating conflicts of interest in medicine, found that each of the researchers had failed to report much of his consulting income to Harvard. Mr. Grassley has also said that Dr. Biederman and Dr. Wilens might have violated federal and university research rules. The controversy led Dr. Biederman to suspend his work with the drug industry.
The subpoena was issued by the Federal District Court for the Massachusetts District; it was sought by the United States attorney in Massachusetts, Michael J. Sullivan, and by the Health and Human Services Department inspector general, Daniel R. Levinson. The subpoena seeks all documents produced in litigation relating to the three researchers as well as transcripts of any depositions of them.
Mr. Trammel said he would “comply with the subpoena and facilitate the U.S. attorney’s investigation in any way I can.”
Peter Spivack, a lawyer for Dr. Biederman, and Mark Paoletta, a lawyer for Dr. Wilens and Dr. Spencer, said they were unaware of a subpoena.
A spokeswoman for Mr. Sullivan declined to comment on the investigation.
Gianna at Beyond Meds posted an incredible interview with Robert Whitaker on Madness Radio. I encourage you to click on the link above to listen to the interview in its entirety and pass it along to everyone you know or link to it at your site.
Here are my thoughts/ramblings on it, which I posted in the comments section:
Gianna, thank you so much for posting this! Well worth 50 minutes of my time. Bob had so many wonderful things to say and I’m really looking forward to his new book!
I would like to see Bob and others like him on shows like, say, The Today Show. If he’s been on this show or similar shows, my apologies, I don’t watch them. People listening to Madness Radio or NPR are not necessarily the crowd that needs to be addressed although there is nothing wrong with it, don’t get me wrong. We need voices like this more than anything right now to pass along this strong and crucial message. However, the majority of us listening to Madness radio, etc already know these facts. We know the problems. We want the Biedermans and Goodwins in jail (well, at least I do!) Part of our problem is simple, the corporations own the networks, they own everything and voices like Bob’s are often silenced. The FDA has issues and on and on… (more…)
I’ll be away for a short time. I finally have a job. I’m helping a director friend of mine cast his next feature film which is set in Portland but shooting mostly here, a city that is the polar opposite of Portland. (in film lingo, difficult to cast) The problem is, I haven’t been in the casting world since 2004, so, I’m a little rusty. No, wrong, more than a little. But I am very thankful for the short-term work. I haven’t had a decent job since last August, basically living off unemployment. I thought I worked in a recession-proof industry but nobody is safe anymore. Well, a few are but I won’t go there. Anyway, I can’t remember the last time I went shopping and bought something for myself or my swain. A friend of mine bought cupcakes for my swain’s birthday a couple of weeks ago, that’s how bad things have been. I can’t even afford to drive 3 hours away to see my sister, parents and meet my niece who was born in October! Or visit my swain’s parents and sister and our newborn niece on that side of the family. Sad. However, I know that it could be so much worse. My dad’s company just cut his salary, my mom is in fear of losing her job-there have been many layoffs at her company. And I’m alive, fairly healthy and not living on the streets. Sooo….before I leave for a bit, a few rambling thoughts. (more…)
My swain just read me an article about this and I didn’t want to believe it. I’m a big fan of Sylvia Plath’s work and her suicide was so very tragic. and now we have learned her son, Nicholas, hanged himself on March 16th. Just terribly sad.
Mr Hughes, whose mother took her own life when he was one, hanged himself at his home in Alaska after battling against depression for some time, according to reports.
He was unmarried with no children of his own and had until recently been a professor of fisheries and ocean sciences at the University of Alaska Fairbanks, the Times reports.
His sister Frieda is travelling to Alaska. She released this statement: “It is with profound sorrow that I must announce the death of my brother, Nicholas Hughes, who died by his own hand on Monday 16th March 2009 at his home in Alaska. He had been battling depression for some time.”
News of his death comes 46 years after Plath gassed herself in the kitchen of the family home while her children slept in a nearby room. Her suicide prompted intense public interest in the family, with some feminist groups laying the blame for her death at the feet of Ted Hughes, who had left Plath for Assia Wevill, the wife of another poet.
He’s the Harvard University psychiatrist who is one of several prominent academics being investigated by the US Senate Finance Committee for allegedly failing to properly disclose payments from the pharmaceutical industry, while also conducting grants for the National Institutes of Health (see background).
In Biederman’s case, he allegedly failed to fully report approximately $1.6 million in consulting fees from various drugmakers between 2000 and 2007, according to the committee. And court documents released late last year suggested he also pushed Johnson & Johnson to fund a research center at Massachusetts General Hospital that would advance J&J’s commercial goals (take a look).
As a result, Biederman is currently enmeshed in litigation in the Superior Court of New Jersey, where three drugmakers – AstraZeneca, Eli Lilly and J&J’s Janssen unit -are being sued in connection with risks associated with their antipsychotic medications. Attorneys for the families who filed suit fought to interview Biederman under oath because his work has been crucial to the widespread acceptance of the pediatric usage of antipsychotics.
Now, though, Biederman is hoping Superior Court Judge Jamie Happas will agree to have his deposition sealed, because he doesn’t want the extent of his involvement with the companies publicized. However, we understand The New York Times is already gearing up for a story, which prompted Biederman’s attorneys to write this letter to Happas.
What’s in the deposition? Dozens and dozens of pages of detail relating to Biederman’s activities, but we encourage you to peruse both sections of the document.
When Biederman is quizzed about his professional ranking at Harvard, well, here is his response:
Lawyer: “What does that mean?”
Biederman: “To move in the ranks from one rank, for example, at Harvard, there is instructor, from instructor you move to assistant professor, from assistant professor you move to associate professor, from associate professsor you move to full professor.”
Lawyer: “Full professor?”
Biederman: “Hm…mmm.”
Lawyer: “What rank are you?”
Biederman: “Full professor.”
Lawyer: “What’s after that?”
Biederman: “God”
Lawyer: “Did you say God?”
Biederman: “Yeah.”
yeah. you read that correctly.
and then there’s this:
Q. And do you agree that you are one of the most forceful advocates of the aggressive treatment of preschoolers?
A.(Biederman)It is her statement about me.
Q.I didn’t ask you if it was her statement about you.I’m asking you if you agree that you are one of the most forceful advocates of the aggressive treatment of preschoolers.
Ray received another involuntary outpatient maintenance electroshock on March 4th. This is approximately his 40th. His next two scheduled electroshocks are March 25th and April 15th.
Please share this video and help stop his forced ECT.
So, you’ve decided to visit three times between and 10:40am and 11:35am. And that was before I posted the link on the story at the Washington Post airing your dirty laundry. Here’s another link, just for fun, from the LA Times where they too have the WP story. You guys can’t buy your way out of this press. It also looks like you noticed the link explaining how patients (we are human beings, not guinea pigs) can now testify in regards to your hearings on applications to have your antipsychotic Seroquel approved by the FDA for depression, anxiety and whatnot. Did you not like the Bob Dylan video in my previous post to you? Well, here’s another version, enjoy it while you can!!!
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Today, AstraZeneca and the Seroquel debacle are on the front page of the Washington Post. I’m posting some of my favorite snippets but I encourage you to read the entire article linked above.
A Silenced Drug Study Creates An Uproar
By Shankar Vedantam
Washington Post Staff Writer
Wednesday, March 18, 2009; Page A01
The study would come to be called “cursed,” but it started out just as Study 15.
It was a long-term trial of the antipsychotic drug Seroquel. The common wisdom in psychiatric circles was that newer drugs were far better than older drugs, but Study 15′s results suggested otherwise.
As a result, newly unearthed documents show, Study 15 suffered the same fate as many industry-sponsored trials that yield data drugmakers don’t like: It got buried. It took eight years before a taxpayer-funded study rediscovered what Study 15 had found — and raised serious concerns about an entire new class of expensive drugs.
Study 15 was silenced in 1997, the same year Seroquel was approved by the Food and Drug Administration to treat schizophrenia. The drug went on to be prescribed to hundreds of thousands of patients around the world and has earned billions for London-based AstraZeneca International — including nearly $12 billion in the past three years.
March 1, 2009
Veterans’ families question cause of deaths
Post-traumatic stress syndrome treatment cited
Stan and Shirley White’s son Andrew, a Marine reservist, died at home 2 1/2 years after he returned from Iraq. Janette Layne lost her husband, Eric, in similar circumstances after his return from Iraq.
More than a year later, they still don’t know if the medication their loved ones were taking for post-traumatic stress disorder contributed to their deaths.
Andrew White and Eric Layne were taking Seroquel, Klonopin and Paxil, along with prescription painkillers.
Three other West Virginia servicemen have died in their sleep while undergoing PTSD treatment after returning from Iraq.
Investigators from the U.S. Department of Veterans Affairs looked into the deaths. Stan White, who actively researches similar deaths and PTSD-related medications, contacted Sen. Jay Rockefeller, who requested the investigation.
The investigators interviewed the White and Layne families and visited Huntington Veterans Affairs, the Charleston Community Based Outpatient Clinic and the Cincinnati VA residential program, where Layne was treated. They reviewed autopsy and toxicology reports for both patients.
In August, they concluded that White and Layne received care that met “community standards” at the VA facilities, and that the men died from a combination of prescribed and non-prescribed medicines.
Although it appears these veterans were taking painkillers on their own, I have a real problem with this story. Why was the VA prescribing three medications (Seroquel, Klonopin and Paxil) to treat PTSD?! Seroquel alone is enough to knock you out and destroy your body. Is this common practice with our veterans returning home from war? I’m too tired to research but I certainly hope not! But, something tells me it is and that is what angers me. I’m reminded of the Chantix/veterans fiasco. I’m tired of reading these stories. A major wake-up call is needed for the FDA, the U.S. Department of Veterans Affairs, VA facilities and our government in general.
Folks, this is so very important. If you have been on Seroquel or you’re taking Seroquel, you know the dangers and side effects of this drug.
Personally, I wish I had the money to go and testify in person. I also wish I had the money to rent a bus (or several) and head to AstraZeneca’s headquarters. We need to be heard. We must at least send a message to the FDA by testifying, this is our chance! If our voices are not heard, this drug will be most likely be approved for depression, anxiety, etc. We cannot let this happen. This is our chance to stop the cycle and save lives.
By now we all know the Wayne MacFadden story, if you don’t, you can find more at this website, google him or click here. I have no idea what the website spoke.com is, but regardless, Wayne is listed there as an employee of J & J.
Wayne Macfadden
Johnson & Johnson
1 Johnson And Johnson Plz
New Brunswick, NJ 08933-0001
Is this why Johnson & Johnson came to my site today via the Seroquel sex emails link? Who knows. But, whoever you are at J & J snooping around-see my post below to AstraZeneca. And I’ll ask you, are you taking Risperdal? Would you *pimp* this drug out to your friends, family members or children?
Of course, if MacFadden is now an employee at J & J maybe it’s him. I can just see him at his computer, popping Vicodin, googling “Wayne MacFadden sex seroquel” and ending up here. Meanwhile, he has a chat window open and he’s furiously typing away, promising to *punish* a girl over at Eli Lilly. Or Wyeth. oh, I give up….
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Hello there. You guys are always here and I think you know my story. What is your name? What is your story? Until you’d like to share, please stop visiting. Or did my last message to you piss you off so much that it left you speechless and you simply couldn’t comment? Or maybe you were sitting at your desk snickering and thinking: another crazy girl who’s gone off her meds! No, I bet I know what it is, you’re taking Seroquel! Your speech is slurred and you can hardly type or put a sentence together! I’m surprised you’re even awake this early, it’s not easy, I know from previous experience! A few more questions for you, my dear reader:
Do you have a child or a friend or a loved one? Is he or she depressed? If so, have you suggested Seroquel for their depression? And lastly, if you are taking Seroquel, have you been to your doctor lately to check for diabetes?
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I’ll end this entry with the great Bob Dylan. Maybe you’ll hear his words over and over in your head today, tomorrow and the next….
I found this video at the lovely and very helpful beyond meds at ning website. Unfortunately, I’ve been sick the past several months and haven’t been able to spend as much time there as I would like. Anyway, this video left me feeling confused and intrigued:
I am interested because today I was reminded of my rape. It’s not an unusual occurrence-it’s a past traumatic experience that is almost always there lingering and sometimes taunting me or shutting me down, etc. Today, some of the many memories came up again. the gravel driveway. my head banging against a tire. the sound of my underwear being ripped off of me. the rest, mostly a blank. a bathtub. my friend holding my hand. blood. wearing nothing but a t-shirt. I was fifteen and then suppressed the events of this evening for nearly four years.
Three key things Dr. John Breeding mentions in this video in regards to healing past trauma(s) are:
take care of yourself
go slow
allow expression
Well, the first two, I don’t know how to do. The third, not a problem. Although I was raised in a home where I felt loved but misunderstood. But, and most importantly, there were rarely any expressions or emotions allowed-we didn’t talk about anything of substance. Pretty much everything was swept under the rug. If you’ve seen the beautiful film “Ordinary People” you’ll have a better picture. I don’t blame my parents for this-I have forgiven them-they were raised this way. My parents also tried to find a quick fix which is what led to my first psychiatrist visit at the age of 13 after I showed signs of depression and voiced suicidal thoughts. Again, I don’t blame them. I imagine they were doing the only thing they knew to do in that situation. That first visit led to over twenty years of psychiatric medications to include: Celexa, Lexapro, Paxil, Prozac, Zoloft, Effexor, Abilify, Seroquel, Remeron, Wellbutrin, Xanax and Lamictal. These are the ones I can remember. And, not one of them worked for more than 2 years. Actually, Lamictal was the only one that seemingly worked that long. I saw many psychiatrists and therapists over the years following my first visit at thirteen. I even checked myself into a mental hospital. NOTHING WORKED. But during all of the above visits, I was always labeled with something-depression, double depression, borderline personality disorder, bipolar-and given meds and ridiculous tools from therapists that never worked.
Here’s where I’m going with this. So, I was raped at 15. But, what happened BEFORE that? Is there a trauma that I’m still blocking/suppressing after all of these years? I’m nearly 36 now. I know why my parents brought me to see that psychiatrist at 13-I repeatedly told them I wanted to die! But, why?!?!? I have absolutely no clue and this concerns me. How does one face and heal from a trauma that does not exist in their mind? My maternal grandmother was deemed mentally ill and spent a lot of time in mental hospitals, she had shock treatments, she was medicated most of her adult life. She died fairly young, due to complications of diabetes, during a very difficult time in my life. I was heavily medicated and we had never once had a discussion about her illness or her life. As I mentioned in a previous entry, I always assumed that I had inherited her “mental illness” but is that what she had? Is that what I have? My grandmother, for example, I know after much digging around and asking my aunts lots of questions, I know that her father burned to his death when she was around five. I’m don’t know anything about her mother, my great-grandmother, I don’t recall ever meeting her. But I do know my grandmother lived in orphanages and foster homes. I’m pretty certain she was sexually abused. So, for some reason, after my great-grandfather died in that fire, my grandmother did not stay at home. I remember my grandmother’s mysterious sister showing up at her funeral and everything was hush hush. Now that I think about it, I believe my grandmother also had a brother and he was not at her funeral.
My grandmother’s life, what I know of it, reeks of trauma. Which is exactly why this video caught my attention. I must blame some really bad doctors and therapists for not addressing and treating the trauma but instead labeling me with whatever they felt suitable, medicating me and moving on to their next patient.
Regardless, I’ll be heading to the library to check out some books while I can’t afford therapy or acupuncture and facing the trauma I know about. First on the list I suppose will be Trauma Through A Child’s Eyes by Peter Levine and Maggie Kline.
Here’s the latest on the AstraZeneca/Seroquel drama:
In the court of public opinion, AstraZeneca is taking a beating over its handling of Seroquel, the blockbuster antipsychotic pill that’s the subject of thousands of consumer lawsuits claiming it caused their diabetes. In the court of law, though, the drug maker is fighting back.
A three-day hearing in Delaware Superior Court last week offered a preview of how AstraZeneca lawyers intend to thwart plaintiffs who blame Seroquel for their diabetes. The company faces lawsuits from more than 15,000 plaintiffs, including hundreds of cases in Delaware, where Seroquel was developed and where AstraZeneca has its U.S. headquarters.
During last week’s hearing — a pretrial proceeding in what could be the first Seroquel case in the country to go to trial — AstraZeneca’s attorneys tried to convince Judge Joseph Slights III to throw out testimony from three expert witnesses who connected Seroquel use to diabetes.
Attorneys and plaintiffs are now watching to see how Slights will rule. A win for AstraZeneca could avert a trial scheduled to start June 29.
now, here is the very interesting part:
The case was brought by Kansas resident Nina Scaife, 46, who started taking Seroquel in May 2003 and was diagnosed with diabetes a year later, according to testimony.
AstraZeneca, which has said that it will litigate each Seroquel case on its individual merits, argued that Scaife’s expert witnesses failed to examine the scientific issues rigorously enough to satisfy legal requirements.
Moreover, the drug maker’s attorneys said, Scaife — and all the other plaintiffs to date — have additional risk factors for diabetes that make it impossible to single out Seroquel as the cause of the disease. In the case of Scaife, for instance, lawyers argued that factors including her obesity and African-American ethnicity had already elevated her risk of diabetes before she took Seroquel.
“I can’t see how the plaintiffs can win,” said Michael Kelly, a Wilmington-based partner in the law firm McCarter & English, who’s slated to try the Scaife case for AstraZeneca.
AstraZeneca is arguing the factors including this woman’s obesity and African-American ethnicity had already elevated her risk of diabetes before she took Seroquel. Really? Disgusting. Well, AstraZeneca, I gained 40 pounds in two months on your lovely drug, Seroquel. I am Caucasian. I was never overweight until I began my journey with psychiatric meds. My grandmother died entirely too young due to complications from diabetes and guess what- she was on psychiatric medications for many, many years.
A question for you, AstraZeneca: Tell me, how many years have you known (and hid the data) that your drug was linked to weight gain and diabetes???? Would you say, for nearly ten years??? And lastly, a note to you, AstraZeneca: excuse my language but, f**k off. you make me sick.
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