The Bitter Pill

The Official Blog of UNITE – uniteforlife.org

Mass. General Recruits Pregnant Women for Bipolar Study on Craigslist

I was going through my office tonight organizing it and filing and trying to write down all the things I want to do. I finally made it through about 10 pounds of paperwork I needed to file (stacking up that much paperwork not yet filed is one of the signs of living a normal life with little boys)! Anyway, I found a printout I had saved from Craigslist from about one year ago.

MGH Drugging Pregnant Moms (Antidepressants / Anticonvulsants)

MGH Drugging Pregnant Moms (Antidepressants / Anticonvulsants)

It was posted 8-27-2008. Says for information you can contact Rachel at 617-726-2912.

I wonder if Rachel ever reads up on the drugs she is helping give to unborn babies.

Filed under: "mood stabilizers", antidepressants, MGH, Pregnancy, , , ,

Pharma Funding of Front Groups Pushing MOTHERS Act – Pringle: MOTHERS Act Fuels Multibillion Dollar Industry

http://www.scoop.co.nz/stories/HL0904/S00076.htm

Mothers Act Fuels Multibillion Dollar Industry

by Evelyn Pringle

Motherhood has fallen prey to the psycho-pharmaceutical complex. If new legislation known as the Mother’s Act becomes law, the drugging of infants through pregnant and nursing mothers will no doubt increase.

Congress has rightfully refused to pass this bill for eight years. The official title is currently the “Melanie Blocker Stokes Mom’s Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act of 2009.”

The legislation was introduced in the House during the 110th Congress on January 4, 2007, by Illinois Democrat Bobby Rush and later reintroduced into both bodies of the new Congress in January 2009, after the bill died in the Senate last year.

Democratic Senator Robert Menendez from New Jersey, home to a large number of drug companies, and Richard Durbin (D-IL) are the main sponsors of the bill in the Senate.

In a March 30, 2009 speech on the House floor, Congressman Rush identified the target of this piece of legislation when he claimed that, “60 to 80 percent of new mothers experience symptoms of postpartum depression while the more serious condition, postpartum psychosis, affects up to 20 percent of women who have recently given birth.”

After the House voted to pass the legislation on that day, the Congressman stated: “H. R. 20 will finally put significant money and attention into research, screening, treatment and education for mothers suffering from this disease.”

However, he only mentions screening and treatment for postpartum depression. The true goal of the promoters of this Act is to transform women of child bearing age into life-long consumers of psychiatric treatment by screening women for a whole list of “mood” and “anxiety” disorders and not simply postpartum depression.

Enough cannot be said about the ability of anyone with a white coat and a medical title to convince vulnerable pregnant women and new mothers that the thoughts and feelings they experience on any given day might be abnormal.

The constant watching and barrage of questions such as are you depressed, are you anxious, are you moody, are you fearful of motherhood, are you sleeping well, are there changes in your eating habits, will predictably have the net effect of convincing many women that normal thoughts and emotions are a sign of mental disorders.

In the March 13, 2008 NewsWithViews article, “Branding Pregnancy as a Mental Illness,” Byron Richards writes:

“The Mothers Act has the net affect of reclassifying the natural process of pregnancy and birth as a mental disorder that requires the use of unproven and extremely dangerous psychotropic medications (which can also easily harm the child). The bill was obviously written by the Big Pharma lobby and its passage into law would be considered laughable except that it is actually happening.”

While mania, psychosis, agitation, hostility, anxiety, confusion, depression and suicidality are often cited as “symptoms” of mental illness, many of the same exact “symptoms” are listed as side effects on the warning labels for antidepressants, antipsychotics and anticonvulsants.

All of these drugs are now being prescribed to treat the “mood” and “anxiety” disorders that women will be screened for if the Act becomes law. In the case of pregnant women, no psychiatric drug has been FDA approved as safe for use.

The newly recruited customers will be stigmatized for life with labels of the most serious forms of mental illness simply because they are unlucky enough to become pregnant in the United States, where serious disorders lead to major profits from the prescribing of multiple classes of psychotropic drugs.

On September 1, 2008, Medical News Today ran a headline for a study that stated: “Americans Show Little Tolerance For Mental Illness Despite Growing Belief In Genetic Cause.” The study by University of Pennsylvania sociology professor Jason Schnittker showed that while more Americans believe that mental illness has genetic causes, the country is no more tolerant of the mentally ill than it was 10 years ago.

The study explored tolerance in terms of: unwillingness to live next door to a mentally ill person, having a group home for the mentally ill in the neighborhood, spending an evening socializing with a mentally ill person, working closely with such a person on the job, making friends with someone with a mental illness or having a mentally ill person marry into the family.

Multi-billion dollar industry

In an article for AlterNet on June 18, 2008, Dr Bruce Levine, author of the book, “Surviving America’s Depression Epidemic,” explains how the psycho-pharmaceutical cartel works. “Mental health treatment in the United States is now a multibillion-dollar industry,” he reports, “and all the rules of industrial complexes apply.”

“Not only does Big Pharma have influential psychiatrists… in their pocket, virtually every mental health institution from which doctors, the press, and the general public receive their mental health information is financially interconnected with Big Pharma.”

“The American Psychiatric Association, psychiatry’s professional organization, is hugely dependent on drug company grants, and this is also true for the National Alliance for the Mentally Ill and other so-called consumer organizations.”

“Harvard and other prestigious university psychiatry departments take millions of dollars from drug companies, and the National Institute of Mental Health funds researchers who are financially connected with drug companies.”

More Democrats than Republicans are supporting the Mother’s Act. The increased campaign funding to Democrats may well explain this turn of events. For the last eight election cycles the pharmaceutical industry has contributed far more to Republicans than Democrats. In the 2006 cycle the percentage was 28% to Democrats and 70% to Republicans, according to the Center for Responsive Politics, a nonprofit group that tracks political funding.

But the Democrats were close to matching the Republicans for the 2008 cycle with $5,099,942 to Democrats compared to $5,680,871 to Republicans, which is probably why the Democrats would allow such an obvious drug marketing scheme to be implemented.

“The Mothers Act, while appearing like an Act of benevolence, is a dangerous and unnecessary measure that will result in the further over-prescription of drugs that are already grotesquely over-prescribed,” says Kate Gillespie, one of the lead attorneys handling SSRI birth defect lawsuits and Paxil suicide cases at the Los Angeles based Baum, Hedlund, Aristei & Goldman law firm.

“The Act is a slippery slope,” she warns, “toward the forced drugging of women of childbearing years with drugs of questionable efficacy and serious safety issues effecting mothers and their innocent children – drugs that can cause horrific side effects, including, suicidal behavior, violence and devastating birth defects.”

“Of course, mothers who truly cannot cope should be helped,” Ms Gillespie says, “but do we really need legislation requiring mothers to be screened and drugged?”

“Take out politics and Big Pharma and the push for this legislation just doesn’t make sense,” she states.

“For politicians, a much safer issue than pushing drugs for pregnant mothers is promoting the expansion of medical treatment for postpartum depression,” according to Dr Levine.

He says the Mother’s Act “omits relevant truths” about Melanie Blocker-Stokes, the woman the bill is named after, and the following information about her suicide should be made known:

“Blocker-Stokes… did in fact receive extensive psychiatric treatment. She was hospitalized three times in seven weeks, given four combinations of anti-psychotic, anti-anxiety, and antidepressant medications, and underwent electroconvulsive therapy (electroshock). But despite her psychiatric treatment — or because of it — Melanie Blocker-Stokes jumped to her death from the twelfth floor of a Chicago hotel.”

“There is no evidence that antidepressant use by depressed mothers lowers their likelihood of suicide,” Dr Levine says, “and there is a great deal of evidence that antidepressant use can make some people manic, agitated, and violent.”

Money-making promoters behind the Act

Katherine Stone runs an internet website called “Postpartum Progress” and posts a daily blog. She also serves on the board of Postpartum Support International as the public relations outreach chairwoman. Her Bio says she “is a nationally-recognized, award-winning advocate for women with perinatal mood and anxiety disorders.”

“In 2001,” Katherine reports on her website, that “she suffered postpartum obsessive compulsive disorder after the birth of her first child. The feeling of isolation and shame she suffered inspired her to create Postpartum Progress, which has become the most widely-read blog in the United States on postpartum depression, postpartum OCD, antepartum depression, postpartum PTSD and postpartum psychosis.”

On another page titled, “The Art of Psychiatric Medication,” Katherine tells women to hang in there if a medication does not work because for her diagnosis of OCD, she states:

“I’ve taken many medications, including Effexor, Celexa, Seroquel, Risperdal, Wellbutrin, Luvox, Cymbalta, etc. Throughout all of them, I was on the road to recovery. Some just worked better than others at treating my symptoms.”

She ends the commentary by telling women: “You will find the right medication for you, and you will get better.”

The prescribing of seven drugs, including two antipsychotics and five antidepressants, to treat OCD is a typical example of the profit-driven drugging that women snagged by the Mother’s Act will face, but it’s a far cry from the description Katherine wrote about regarding the comparatively minor treatment she received, when she stated in the June 7, 2004 issue of Newsweek, “in my case, that meant taking an antidepressant and going for weekly therapy sessions.”

Aside from all the serious health risks now known to be associated with these drugs, most women could not afford the 7-drug “cure” that Katherine ingested. According to DrugStore.com in December 2008, from first to last, at a middle dose for a 30-day supply, the drugs would cost: Effexor $197.86, Celexa $279.92, Seroquel $388.38, Risperdal $652.07, Wellbutrin XI $202.08, Luvox CR $135.99, and Cymbalta $366.62. The cost of “etc” is impossible to calculate without knowing how many more drugs she took.

In a March 11, 2009 Postpartum Progress blog, Katherine plugs herself for speaking jobs, along with a study that concluded “the Internet is a viable and feasible tool to screen for PPD.”

“I’ll be adding this study to the speech I give on how women with perinatal mood and anxiety disorders use the Internet,” she reports, and then adds:

“If you’re interested in having me speak at your event, let me know!”

On March 10, 2009, Katherine’s headline read: “It’s Petition Signing Time! Get Out Your Virtual Pen & Support Women with PPD”, and reported “that Susan Stone over at Perinatal Pro is alerting everyone to the new petition created by the Depression and Bipolar Support Alliance to support the Melanie Blocker Stokes MOTHERS Act. She states that last year’s petition generated more than 24,000 signatures. The petition has been reintroduced this year to try and get this legislation passed once again.”

The blog carried a live link to a page where “you can scroll down, enter your zip code and generate letters of support in a matter of seconds for the Melanie Blocker Stokes MOTHERS Act that will be sent to your local Congresspeople and Senators.”

Katherine further told readers: “I know you’re thinking ‘but I already did that last year.’ Well that was then and this is now. Do it again.”

The 2007 Annual Report for the Depression and Bipolar Support Alliance shows this Big Pharma front group received between $150,000 and $499,000 from AstraZeneca, Pfizer, and Wyeth. Abbott Labs, Cyberonics, Eli Lilly, Forest Labs, GlaxoSmithKline, Organon, and Otsuka American Pharmaceuticals each gave between $10,000 and $149,999.

The 2006 Annual Report shows that AstraZeneca gave the group more than $500,000. Abbott Labs, Bristol-Myers Squibb and Wyeth gave between $150,000 and $499,000, and Forest Labs, Glaxo, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000. The Depression and Bipolar Support Alliance in Baltimore also received $5,000 from Eli Lilly in the first quarter of 2008, according to Lilly’s grant report.

In the section of the 2007 Annual report “at a Glance: How We Met Our Mission,” among the things accomplished by the group, it states:

“Promoted Melanie Blocker-Stokes Postpartum Depression Research & Care Act at invitation of Rep. Bobby Rush (D-Ill.)

“Promoted MOTHER’s Act at invitation of Sen. Dick Durbin (D-Ill.)”

After writing letters to Congress through the link established by the industry funded Alliance, those visiting Postpartum Progress will hopefully click on the link to Amazon and buy the book “Perinatal and Postpartum Mood Disorders: Perspectives and Treatment Guide for the Health Care Practitioner” by none other than the Perinatal Pro “expert,” Susan (Dowd) Stone, and Alexis Menkin, at a special price of $43.20, for a savings of $10.80.

Katherine also provides a link to the PerinatalPro website, where women can find treatment for all the “mood” and “anxiety” disorders diagnosed with internet screenings atBlue Skye Consulting,” where Susan is listed as the Managing Director and Owner.

She also served as president of Postpartum Support International from 2006 – 2008, as vice-president and Conference Chair in 2005 – 2006, and will chair the group’s President’s Advisory Council through 2010. This group brags of being the leading proponent of the Mother’s Act. On March 2, 2009, Susan’s PerinatalPro Blog announced: “The Melanie Blocker Stokes MOTHERS Act moves forward!” and stated:

“Thank you to Congressman Bobby L. Rush, U.S. Senator Robert Menendez and Senator Richard Durbin for your unceasing efforts on behalf of America’s mothers!”

She should have thanked these members of Congress for boosting her career status and yearly income from her treatment center, speaking fees and book sales.

On PerinatalPro, Susan posts a running list of supporters for the Mother’s Act. On March 27, 2009, the list included many drug company funded groups. For instance, the American Psychiatric Association is listed as a supporter. In 2006, the pharmaceutical industry provided close to 30% of the Association’s $62.5 million in financing, according to the July 12, 2008 New York Times.

In the first quarter of 2007, Eli Lilly gave the Association grants worth more than $412,000, according to Lilly’s grant report. The group also received $623,190 from Lilly in the first quarter of 2008.

In her PerinatalPro blogs, Susan has nothing but praise for Katherine’s website and directs visitors back to Postpartum Progress with a live link. On March 16, 2009, Katherine posted a “Quick Survey on Postpartum Anxiety,” and wrote:

“The fabulous Karen Kleiman has asked me to ask you to participate in a short, five-question online survey on anxiety. She says ANYONE can answer it, regardless of the age of their baby(s) and regardless of diagnosis or lack thereof. ANY mother should answer the questions. It’s super quick — I know because I took it myself.”

Kleiman must be fabulous because she has three books for sale on Postpartum Progress with links to purchase them on Amazon. In fact, there are a total of fourteen books for sale on Katherine’s site from which she most likely gets a kick-back with every sale.

Kleiman’s survey is an excellent example of the methods used to con women into suspecting they are mentally ill via the “expert” blogs. The preface states: “The questions on this survey can be answered by a new mother of an infant or an empty-nester with good recall of the early days with her baby. Please answer as honestly as you can.”

The question, capital letters and all, reads: “When you were carrying your baby down a flight of stairs, did you EVER, at ANY time, have ANY thought, image or concern that you could accidentally drop your baby?” The survey further tells women:


If you answered YES to the first question, please describe the type of worry you had:
Scary thoughts about dropping the baby, Scary images about dropping the baby, Both thoughts and images, Other.

How much distress did this cause you? A Great deal of distress, Some distress but I quickly got over it, Some distress that seemed to linger, Not much stress

Did this thought or image occur once or did it recur? Only once, It recurred frequently, It recurred persistently, It occurred off and on, Did you ever tell anyone about the fear of dropping the baby? (Please describe why you chose to tell someone or why you chose not to)

As a mother with good recall, the “honest” answer is yes, with two babies born 4 years apart, every single night as I stumbled out of bed half asleep for a nightly feeding, my normal fear instinct kicked in and warned me to be careful not to trip and fall down the stairs or drop the baby.

Women who take the survey are told nothing about what the results mean; but clearly the seed is planted that something is wrong if you “EVER, at ANY time, have ANY thought, image or concern that you could accidentally drop your baby”.

Katherine’s website also provides links to the “Top Women’s PPMD Treatment Programs & Specialists.” The first link on the list takes women to the “Emory Women’s Mental Health Program” that primarily focuses on “the evaluation and treatment of emotional disorders during pregnancy and the postpartum period,” according to Emory University’s website. Lilly’s 2008 first quarter grant report shows Emory’s Department of Psychiatry received $25,000.

The “experts” at Emory include some top pharmaceutical industry shills. For example, a link to “Articles” brings up roughly 90 studies and papers that include the co-author Dr Charles Nemeroff. Nemeroff is on an ever-growing list of academic researchers in the field of psychiatry under investigation by the US Senate Finance Committee for not disclosing millions of dollars of income from the makers of psychotropic drugs.

Emory’s investigation found he was paid more than $960,000 by Paxil maker, GlaxoSmithKline, from 2000 through 2006, but listed less than $35,000 on his Emory disclosure forms. All totaled, Nemeroff had earnings of $2.8 million from speaking and consulting arrangements with drug companies between 2000 and 2007, but only disclosed a fraction of that amount, according to the Senate Finance Committee reports.

On July 23, 2008, Medscape Psychiatry & Mental Health posted an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and Post Partum”. On March 17, 2009, the Medscape website stated: “This article is temporarily unavailable.”

Maybe that’s because the “top expert,” Dr Nemeroff, recently stepped down as chairman of Emory’s psychiatry department.

************* epringle05@yahoo.com

(Article sponsored by the Baum, Hedlund, Aristei & Goldman law firm www.baumhedlundlaw.com)

(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)

Filed under: Melanie Stokes, MGH, mothers act, PPD, Pregnancy, shrinks disciplined, The Future of The United States

In Memory of Indiana (Effexor Baby)

I recently got in touch with a woman who signed the petition against The MOTHERS Act after reading the comment that she had lost her 6 week old daughter and believes it was Effexor that caused her death. Luckily I was able to find her on Facebook because Care2 doesn’t give me the emails of the people who sign the petition unless I have to verify their identity.

I am working on a story and video about this, but I just can’t finish it today, and I can’t sit here and not scream at the top of my lungs to the world about this little baby.

Christian Delahunty is Indiana’s mom and she was told by her doctor that Effexor doesn’t even pass to the baby during pregnancy or breastfeeding. However when she was induced one month before her due date because of problems with the pregnancy, Christian’s OB called down to the NICU to tell them to be ready because an Effexor baby would be coming.

This is Indiana.

Bath time

Bath time

With Mommy

With Mommy

sweet baby

sweet baby

Sleeping with a butterfly on her head

Sleeping with a butterfly on her head

Indiana in a tie dye dress

Indiana in a tie dye dress

Indiana with Dad

Indiana with Dad

Indiana's Funeral

Indiana's Funeral

Indiana was found not breathing and rushed to the hospital. She was revived and put on life support, but her brain was deteriorating and it was too late for her.

Drug company studies and FDA reports confirm that SIDS, coma, seizures, stillbirth, birth defects, miscarriage (“spontaneous abortion”), and an increase in neonatal deaths are linked to exposure to antidepressants. All you have to do is look at the drug label for Effexor and see the animal studies to understand the effects on babies.

“[T]here was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known.”

c.

See also (a warning about often fatal serotonin syndrome – serotonin being the brain chemical researchers think is involved in SIDS due to its role in regulating breathing and sleep and wake cycles. Serotonin Syndrome is what most likely killed Heath Ledger and we know that these drugs can kill adults and children, and are especially hard on babies who have a hard time metabolizing the drugs and who have immature blood-brain barriers): http://www.fda.gov/CDER/drug/infopage/effexor/default.htm

And http://anxiety.emedtv.com/effexor-xr/effexor-xr-and-pregnancy.html

Also, here is a website where you can look through all the MedWatch Reports for a four year period of 2003-2007 (select Effexor and you find 6 reports of SIDS among the other infant deaths and other reports): http://www.psychdrugdangers.com/MothersAct.html

We know that these reports represent the tip of the iceberg, with the FDA estimating that between 1-10% of actual adverse events being reported.

I can’t imagine how hard this must be for Christian and her family but I am so glad that she reached out and wants to tell Indi’s story. I was telling my husband today how lucky I felt that our kids are safe and healthy. My doctor told me it was safe to breastfeed Isaac on Zoloft and that I could stay on it during pregnancy. There were times when it seemed like Isaac had stopped breathing and I would nudge him to make him start up again. Like many moms out there at the time I thought I didn’t know better than my doctor and that I could trust him.

Please take this as a warning of what could happen if you use antidepressants when you’re pregnant and breastfeeding. Christian says that Indiana was in and out of the hospital after she was born so obviously this was more than just a random case of SIDS. This is just one example of a mom who went on antidepressants after the birth of a previous child for PPD and the loss of a loved one (her mom) and then stayed on them at the recommendation of her doctor. How many others out there are like her?

I know this deserves more time and a much better write-up, but I feel like I can’t keep this off the blog even though Indi’s story is much bigger than just this post. Here’s hoping that this will somehow reach someone else in time to save their baby. I know that is all Christian can hope for and will help Indiana’s purpose to be realized.

You’ll be seeing more about Christian and Indi and their family very soon.

Filed under: "prevention", antidepressants, Christian Delahunty, Congress, Effexor in pregnancy, FDA, FDA Warnings, Indiana, Julie Edgington, Manie, Melanie Stokes, MGH, mothers act, Paxil in pregnancy, PPD, Pregnancy, , , ,

SSRI birth Defects: Why Weren’t Warnings Issued Sooner?

http://www.lawyersandsettlements.com/articles/11869/paxil-defects-birth-side-effects-12.html

 

February 6, 2009. By Lucy Campbell

Valley Home, AK: When Susan (not her real name) gave birth to her now 5-year old son, he had a lung and heart deformity. Susan had taken the anti depressant Zoloft, albeit briefly, during her pregnancy, and given all she’s subsequently read, now wonders if her son’s birth defects are SSRI-related birth defects.

Pregnant MedicationWhen Susan’s son was born, he wasn’t breathing. The medical staff had to resuscitate him and place him in an incubator. He was then diagnosed with pectus excavatum. “It’s a lung and heart ‘deformity’ I guess you would call it,” Susan said. “It’s supposed to be hereditary but no one in our family has this. My son also has breathing problems, and some type of brain damage which had to be in uterus and caused oral and verbal apraxia.” 

Apraxia is an impairment of the nerves or nervous system that affects a person’s ability to plan, execute and sequence motor movements. Verbal apraxia affects the programming of the articulators and rapid sequences of muscle movements for speech sounds. Oral apraxia involves nonspeech movements e.g., blowing, puckering, licking food from the lips – those kinds of things.

“My son didn’t talk until much later than is considered normal,” said Susan. “When he was 2 he just mumbled. And there were other things like he couldn’t put his tongue in his cheek, for example. He went to speech therapy for 2 years; that helped.”

So far, Susan has yet to receive any kind of diagnosis for her son, beyond those given when he was born, making treatment difficult. “He’s been tested for Autism, and the results were negative, but he does have behavioural problems, like anxiety and disruptive behaviour,” she said. “They think he has sensory processing disorder – but they haven’t given him a diagnosis of that. At one point they thought he had ADHD, and wanted to give him drugs for that but I refused.”

Not surprisingly, Susan has been doing a lot of reading, prompted in part by a need to try and understand what’s happening to her son, and in part by an ad she saw on television some time ago, describing SSRI birth defects.

“I saw a TV commercial and it got me thinking. I never thought that Zoloft may have played a role in his health problems, because my doctor said it was okay to take it,” Susan said.” I’ve read a lot, and I try to help my son. I love him, and I will do what I can for him. I wonder what the outcome would have been if I hadn’t taken Zoloft. As a parent, I want to know why this has happened – what caused it – because it would provide some kind of closure.” 

SSRIs–also known as selective serotonin reuptake inhibitors–are a class of antidepressant. Until about 2005 there were no real warnings of the possibility of birth defects connected with the use of these drugs during pregnancy. All that changed, however, in 2005, when the first public warnings emerged from the Food and Drug Administration (FDA) about the potential for serious heart defects in babies born to women taking SSRI antidepressants during pregnancy. 

SSRI Birth Defects
Susan’s son was born in 2004, before any of the public warnings were issued, together with the studies showing the link between birth defects and SSRI use in pregnancy. 

To say that the situation Susan and her son are in is frustrating would be an understatement. Had Susan known in advance of the possible consequences, she would not have taken an SSRI during her pregnancy. 

Worse, Susan is not the only mother with questions. There are many women with similar stories to tell. Chief among the many questions they would like answered is why weren’t the warnings issued sooner?

Filed under: antidepressants, Baum Hedlund, Birth Defects, child endangerment, lawsuits, Melanie Stokes, MGH, mothers act, Paxil in pregnancy, PPD, Pregnancy

Massachusetts General Hospital Research Center Tied to Drug Company

November 25, 2008
The New York Times
Research Center Tied to Drug Company

By GARDINER HARRIS
http://www.nytimes.com/2008/11/25/health/25psych.html?_r=1


When a Congressional investigation revealed in June that Dr. Joseph Biederman, a world-renowned child psychiatrist, had earned far more money from drug makers than he had reported to his university, he said that his interests were “solely in the advancement of medical treatment through rigorous and objective study.”

But e-mail messages and internal documents from Johnson & Johnson made public in a court filing reveal that Dr. Biederman pushed the company to finance a research center at Massachusetts General Hospital, in Boston, with a goal to “move forward the commercial goals of J.& J.” The documents also show that the company prepared a draft summary of a study that Dr. Biederman, of Harvard, was said to have written.

Dr. Biederman’s work helped to fuel a fortyfold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder and a rapid rise in the use of powerful, risky and expensive antipsychotic medicines in children.

Although many of his studies are small and often financed by drug makers, Dr. Biederman has had a vast influence on the field largely because of his position at one of the most prestigious medical institutions.
Massachusetts General said in a statement Monday that it took the accusations related to the research center “very seriously” and intended “to investigate these issues thoroughly.”

Johnson & Johnson makes a popular antipsychotic medicine called Risperdal, or risperidone. More than a quarter of its use is in children and adolescents.

Last week, a panel of federal drug experts said that medicines like Risperdal were being used too cavalierly in children and that regulators must do more to warn doctors of their substantial risks. Other popular antipsychotic medicines, also referred to as neuroleptics, are Zyprexa, made by Eli Lilly; Seroquel, made by AstraZeneca; Geodon, made by Pfizer; and Abilify, made by Bristol-Myers Squibb.

Thousands of parents have sued AstraZeneca, Eli Lilly and Johnson & Johnson, claiming that their children were injured after taking the medicines; they also claim that the companies minimized the risks of the drugs.

As part of the lawsuits, plaintiffs’ lawyers have demanded millions of documents from the companies. Nearly all have been provided under judicial seals, but a select few that mentioned Dr. Biederman became public after plaintiffs’ lawyers sought a judge’s order to require Dr. Biederman to be interviewed by them under oath.

In a motion filed two weeks ago, lawyers for the families argued that they should be allowed to interview Dr. Biederman under oath because his work had been crucial to the widespread acceptance of pediatric uses of antipsychotic medicines. To support this contention, the lawyers included more than two dozen documents, among them e-mail messages from Johnson & Johnson that mentioned Dr. Biederman. A judge has yet to rule on the request.

The documents offer an unusual glimpse into the delicate relationship that drug makers have with influential doctors.

In a November 1999 e-mail message, John Bruins, a Johnson & Johnson marketing executive, begs his supervisors to approve a $3,000 check to Dr. Biederman as payment for a lecture he gave at the University of Connecticut.

“Dr. Biederman is not someone to jerk around,” Mr. Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”

Mr. Bruins wrote that Dr. Biederman was furious after Johnson & Johnson rejected a request that Dr. Biederman had made for a $280,000 research grant. “I have never seen someone so angry,” Mr. Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”

Mr. Bruins concluded that unless Dr. Biederman received a check soon, “I am truly afraid of the consequences.”

A series of documents described the goals behind establishing the Johnson & Johnson Center for the study of pediatric psychopathology, where Dr. Biederman serves as chief.

A 2002 annual report for the center said its research must satisfy three criteria: improve psychiatric care for children, have high standards and “move forward the commercial goals of J.& J.,” court documents said.

“We strongly believe,” the report stated, “that the center’s systematic scientific inquiry will enhance the clinical and research foundation of child psychiatry and lead to the safer, more appropriate and more widespread use of medications in children.

“Without such data, many clinicians question the wisdom of aggressively treating children with medications, especially those like neuroleptics, which expose children to potentially serious adverse events.”

A February 2002 e-mail message from Georges Gharabawi, a Johnson & Johnson executive, said Dr. Biederman approached the company “multiple times to propose the creation” of the center. “The rationale of this center,” the message stated, “is to generate and disseminate data supporting the use of risperidone in” children and adolescents.

Documents show that Johnson & Johnson gave the center $700,000 in 2002 alone. Massachusetts General said in its statement on Monday that grant agreements indicated the center “was for scientific and educational purposes only and not for purposes of promoting, directly or indirectly, the products of Johnson & Johnson and its affiliates.”

A statement Monday from Janssen Pharmaceutica, a unit of Johnson & Johnson, said it helped finance the research center in 2002 “with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

A June 2002 e-mail message to Dr. Biederman from Dr. Gahan Pandina, a Johnson & Johnson executive, included a brief abstract of a study of Risperdal in children with disruptive behavior disorder. The message said the study was intended to be presented at the 2002 annual meeting of the American Academy of Child and Adolescent Psychiatry.

“We have generated a review abstract,” Dr. Pandina wrote, “but I must review this longer abstract before passing this along.”

One problem with the study, Dr. Pandina wrote, is that the children given placebos and those given Risperdal both improved significantly. “So, if you could,” Dr. Pandina added, “please give some thought to how to handle this issue if it occurs.”

The draft abstract that Dr. Pandina put in the e-mail message, however, stated that only the children given Risperdal improved, while those given placebos did not. Dr. Pandina asked Dr. Biederman to sign a form listing himself as the author so the company could present the study to the conference, according to the message.

“I will review this morning,” responded Dr. Biederman, according to the documents. “I will be happy to sign the forms if you could kindly send them to me.” The documents do not make clear whether he approved the final summary of the brief abstract in similar form or asked to read the longer report on the study.

Drug makers have long hired professional writers to compose scientific papers and then recruited well-known doctors to list themselves as the author. The practice, known as ghostwriting, has come under intense criticism recently, and medical societies, schools and journals have condemned it.

In June, a Congressional investigation revealed that Dr. Biederman had failed to report to Harvard at least $1.4 million in outside income from Johnson & Johnson and other makers of antipsychotic medicines.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked by Senator Charles E. Grassley, an Iowa Republican who is leading the Congressional inquiry, to check again, Dr. Biederman said he had received $3,500. But Johnson & Johnson told Mr. Grassley that it paid $58,169 to Dr. Biederman in 2001.

A Harvard spokesman, David J. Cameron, said Monday that the university was still reviewing Mr. Grassley’s accusations against Dr. Biederman. Mr. Cameron added that the university had not seen the drug company documents in question and that it was not directly involved in the child psychiatry center at Massachusetts General.

Calls to Dr. Biederman were not returned.

Filed under: antipsychotics, MGH, , , , ,

Blood Money: J&J Buys Positive Risperdal Pediatric “Studies”

J&J gave money in return for positive drug studies, court documents say

Johnson & Johnson gave hundreds of thousands of dollars to a research center run by an influential child psychiatrist explicitly to generate data to help expand sales of the company’s antipsychotic drug Risperdal in children, according to court documents.The documents shed new light on Johnson & Johnson’s close relationship with Joseph Biederman, a Harvard University psychiatrist at the center of a controversy involving the dramatic increase in antipsychotic drugs, including Risperdal, prescribed for children, often for unapproved uses.

Johnson & Johnson spent at least $700,000 to fund the Johnson & Johnson Center for Pediatric Psychopathology at Massachusetts General Hospital. The purpose of the center, according to an internal company e-mail contained in the court documents, was to “generate and disseminate data supporting the use” of Risperdal in children and adolescents.

Risperdal is used to treat bipolar disorder and schizophrenia.

The e-mails were from 2001 and 2002, long before the U.S. Food and Drug Administration approved Risperdal for use in children in 2006. Physicians are allowed to prescribe drugs for unapproved uses or patients, but drugmakers are barred from marketing drugs for such off-label uses and can face civil charges and steep fines.

Officials at Ortho-McNeil-Janssen Pharmaceuticals Inc., the Johnson & Johnson subsidiary in Titusville, N.J., that makes Risperdal, said they funded the center “to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children.”

The company said it promoted its products “only for their FDA-approved indications.”

Biederman did not return a phone call.

The documents were provided by plaintiff lawyers pursuing a class-action suit against Johnson & Johnson, contending that such a powerful drug should not have been widely recommended for children.

The court papers show Johnson & Johnson:

Budgeted $6.4 million to hold “educational summits” and sponsor advisory panels in part to counter negative media reports on the research, diagnosis and treatment of children with mental illness;

Was actively involved in drafting research that Biederman was to present at a medical conference and asked him how to deal with unfavorable research results suggesting that a placebo worked as well as Risperdal;

Discussed clinical trials for drugs as “growth opportunities” and tied trial proposals to sales potential.

Biederman is a Harvard researcher and psychiatrist whose work has fueled a rapid rise in diagnoses of bipolar disorder in children. His studies, often on small numbers of children and funded by drug companies, have expanded the use of what are known as atypical antipsychotics in children.

Children are believed to be much more vulnerable to the side effects of these drugs, which include weight gain, breast milk production in both sexes, facial tics and muscle tremors.

Last Tuesday, a panel of federal drug experts said antipsychotic medicines were overused in children and urged the Food and Drug Administration to do more to warn doctors of their risks.

Besides Risperdal, atypical antipsychotics include Zyprexa, made by Eli Lilly & Co.; Seroquel, made by AstraZeneca P.L.C. and others.

The documents, which resulted from discovery efforts in the lawsuits, portray Biederman as using his influence to get money out of Johnson & Johnson.

In an e-mail from November 1999, for example, Johnson & Johnson marketing executive John Bruins warned his bosses to quickly issue a $3,000 check to Biederman to pay for a lecture.

“Dr. Biederman is not someone to jerk around,” Bruins wrote. “He is a very proud national figure in child psych and has a very short fuse.”

Bruins also suggested that Biederman had taken business away from Johnson & Johnson after the company turned down the doctor’s request for a $280,000 research grant. “I have never seen someone so angry,” Bruins wrote. “Since that time, our business became non-existant (sic) within his area of control.”

In the court documents, e-mails from Johnson & Johnson executives said Biederman had asked the company to fund a pediatric research institute at Massachusetts General Hospital, resulting in a donation of at least $700,000 in 2002. Biederman is listed as the chief of the Johnson & Johnson Center for Pediatric Psychopathology.

Biederman is the subject of investigations by Harvard and by Sen. Charles Grassley (R., Iowa) for failing to disclose to Harvard at least $1.4 million in funds from Johnson & Johnson and other companies. Laws require researchers to disclose such relationships to their employers, to protect the integrity of medical research.

Massachusetts General said yesterday in a statement that it planned to investigate the allegations raised in the court documents.

Harvard said it was not connected to Massachusetts General Hospital or to the pediatric institute there. A university spokesman said he could not comment on Harvard’s review.

Biederman first told Grassley he had received $3,500 from Johnson & Johnson, but the company told the senator’s office the figure was $58,169 in 2001.

 


Contact staff writer Miriam Hill at 215-854-5520 or hillmb@phillynews.com. 

Filed under: Charles Grassley, Congress, MGH, , , ,

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