Glaxo Taking Focus off of Antidepressants
February5, 2010
The Wall Street Journal
By Jeanne Whalen
GlaxoSmithKline PLC said it will stop research into new antidepressants and focus on diseases for which it believes it can develop more valuable drugs, a major shift for a company that developed some of the biggest-selling antidepressants of the past 20 years.
Profits at the U.K. drug giant, which posted a 66% increase in fourth-quarter earnings Thursday, were long fueled by the antidepressants Paxil and Wellbutrin, which at their peak generated billions of dollars a year in sales. Similar medicines, such as Eli Lilly & Co.’s Prozac and Pfizer Inc.’s Zoloft, also generated big sales for those companies.
However, low-cost …
Antidepressants May Complicate Breast-Feeding
January 27th, 2010
WebMD Health News
By Salynn Boyles
Early research suggests a link between antidepressant use and breastfeeding difficulties in new moms.
The risk of delayed lactation after giving birth was twice as great among women in the study taking selective serotonin reuptake inhibitor (SSRI) antidepressants as among new mothers who did not take the drugs.
Just eight, or about 2%, of the 431 study participants were taking the antidepressants, however, so the findings are far from conclusive.
But the study is the first to explore the impact of antidepressant use on lactation in humans.
“Delayed lactation is very common in the United States, but we don’t really understand the reasons for it,” researcher Nelson D. Horseman, PhD, of the University of Cincinnati College of Medicine tells WebMD. “This may end up being one of the few concrete explanations for at least some of the delayed lactation we see.
“Earlier research in Nelson’s lab found that the hormone serotonin plays a role in breast function, including the ability to secrete milk when needed.
The finding led the researchers to wonder if drugs that affect serotonin levels, such as SSRI antidepressants, would also affect the ability of the breasts to secrete milk when needed.
SSRIs are the most widely prescribed antidepressants. They include the drugs Zoloft, Celexa, Prozac, Paxil, and Lexapro.
In an effort to answer the question, Nelson and colleagues followed 431 first-time mothers from childbirth through the first days of motherhood.
For the purposes of the study, the researchers considered breastfeeding delayed when a woman did not have copious milk production within three days, or 72 hours, of giving birth.
All the women in the study were eventually able to breastfeed, whether they were taking antidepressants or not.
But the average time to lactation for the eight women taking SSRIs was almost 86 hours after childbirth, which was almost a day later than the average time it took women who did not take the antidepressants to establish a milk supply.
Lactation specialist Laurie Nommsen-Rivers, PhD, tells WebMD that this extra day can be the difference between success or failure for women anxious to provide their babies nutrition.
A co-author of the study, Nommsen-Rivers is also an epidemiologist with Cincinnati Children’s Hospital Medical Center. “That delay can be the point where many women throwing in the towel and decide they can’t breastfeed,” she says. “It is important to point out that all the women in our study eventually lactated. SSRI use doesn’t prevent women from breastfeeding, but it might take SSRI users a little longer.
“Nommsen-Rivers says that while all new moms should have access to breastfeeding support, such support may be especially important for new moms who take antidepressants.
The study appears in the February issue of the Journal of Clinical Endocrinology and Metabolism.
“These women need to know that delay doesn’t mean it isn’t going to happen,” she says.
Texas Tech University Medical School health psychologist and lactation consultant Kathleen Kendall-Tackett, PhD, points to numerous studies that have explored the impact of SSRIs on babies born to women who use them.
“To my knowledge this lactation delay has not been documented before,” she tells WebMD. “I would guess that if this is happening, it is rare.”
She points out that pregnant women are at the highest risk for depression in their last trimester and in the early weeks after giving birth.
While she feels too many women may be taking antidepressants when other treatments might work for them, Kendall-Tackett also warns that moms-to-be and new moms should never stop taking SSRIs or any other prescribed antidepressant without their doctor’s approval.
“Generally speaking, if a woman is on an antidepressant during the last trimester of pregnancy she probably needs to stay on it, and she should never go off it on her own,” she says.
Click here for the full report
Antidepressants Alter Your Personality
December 9, 2009
Los Angeles Times
By Melissa Healy
Peter D. Kramer, the psychiatrist and author of the path-breaking 1993 book “Listening to Prozac,” said in an interview today that he felt “vindicated” by a newly published study (“Personality Change During Depression Treatment,” by Tony Z. Tang et al) finding that selective serotonin reuptake inhibitor (SSRI) antidepressants cause dramatic personality changes in depressed patients who take them.
“It’s hard not to feel justified” in the view–offered long before it became fashionable–that antidepressants now taken by 7% of American adults do more than lift depression: They nudge underlying personalities–even those of healthy people–into brighter, more appealing territory, and in so doing, raise ethical concerns about “cosmetic psychiatry.”
The study offers evidence that people who are unassertive, pessimistic, prone to worry and prefer to be by themselves or in small groups are more likely to develop depression, and that, when they take SSRIs, those underlying personality traits change more than most peoples’ change in an adult lifetime–in the span of 16 weeks. That change in basic outlook not only seems to be the thing that lifts them out of depression; it may even reduce the likelihood that they’ll relapse. (You can read our detailed account of the study and its findings here.)
While a group of subjects undergoing cognitive therapy had some of the same effects, they weren’t nearly as powerful as those that came from a pill–which in this case was paroxetine, marketed as Paxil.
Kramer found one possible inference from the study particularly striking: that it might turn on its head the view that many clinicians have of the value of drugs and/or cognitive therapy for their patients. “It looks like medicine is good for chronic personality traits and cognitive therapy is good for acute illness,” he said. Translation: Maybe any of us who are given to sad or worried rumination should be on SSRIs, and then, if we fall into depression anyway, we can get some time-consuming and expensive cognitive therapy. (That DOES sound like a treatment algorithm that would appeal to insurance companies.)
Paxil Causes Heart Defects in Babies
October 15, 2009
Telegraph UK
GlaxoSmithKline Plc, the British manufacturer of Seroxat, said it would appeal against the verdict in the case, which is the first of 600 such cases to come to trial.
Jurors in state court in Philadelphia deliberated about seven hours over two days before finding Glaxo failed to properly warn doctors and pregnant users of Paxil’ s risk. The panel awarded $2.5 million in compensatory damages to the family of Lyam Kilker. The 3-year-old was born with heart defects his mother blamed on the drug.
“The first win is always huge, especially when you get a jury saying the drug caused the injury,” Sean Tracey, the family’ s lawyer, said after the verdict.
The drug, approved for US use in 1992, generated about $942 million in sales last year, or 2.1 per cent of Glaxo’s total revenue.
The company said in a statement: “While we sympathise with Lyam Kilker and his family, the scientific evidence does not establish that exposure to Paxil during pregnancy caused his condition.”
Glaxo American depositary receipts, each representing two ordinary shares, fell 9 cents to $39.69 at 4:02 pm in New York Stock Exchange composite trading, after dropping as much as 1.4 per cent when the verdict was announced. Glaxo dropped 14 pence, or 1.1 per cent, to 1,246.5 pence in London.
In the Kilker case, jurors found 10-2 that Glaxo officials “negligently failed to warn” the doctor treating Lyam’s mother about Paxil’s risks and concluded the medicine was a “factual cause” of the child’ s heart defects.
Glaxo is also fighting suits in the US, Canada and Britain over claims that Paxil, whose generic name is paroxetine, causes homicidal and suicidal behaviour. The company settled some suicide claims, under undisclosed terms.
In 2004, the drugmaker agreed to pay the state of New York $2.5 million to resolve claims that officials suppressed research showing Paxil may increase suicide risk in young people. The settlement required Glaxo to publicly disclose the studies.
In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled while on appeal, according to Glaxo’s spokesman. \
Click here for the full report.
Glaxo Used Ghostwriting Program to Promote Paxil
August 19, 2009
ABC News
By Matthew Perrone
Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.
An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
Known as the CASPPER program, the paper explains how the company can help physicians with everything from “developing a topic,” to “submitting the manuscript for publication.”
The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects.
A spokeswoman for London-based Glaxo said the published articles noted any assistance to the main authors.
“The program was not heavily used and was discontinued a number of years ago,” said Mary Anne Rhyne.
According to the memo, which dates from April 2000, the CASPPER program was designed to “strengthen the product positioning and overcome competitive issues.”
At the time, Paxil was competing with rival antidepressant blockbusters like Eli Lilly’s Prozac and Pfizer’s Zoloft. Paxil has since lost its patent protection and competes against cheaper generic versions. Sales of Paxil last year totaled $849 million.
Drug companies frequently hire outside firms to draft a manuscript touting a company’s drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work.
But the use of ghostwriting by drug companies has come under increased scrutiny by members of Congress, including Sen. Charles Grassley, R-Iowa, a longtime critic of the industry’s influence over physicians. Grassley and Sen. Herb Kohl, D-Wis., are pushing a bill that would require companies to disclose all payments to physicians over $100.
According to ghostwriting expert Dr. Leemon McHenry, Glaxo’s program was unusually intertwined with its internal sales and marketing department.
“We know that GSK has engaged in ghostwriting for many years,” said McHenry, who works as a research consultant for Baum Hedlund. “But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients.”
McHenry acknowledged that ghostwriting is legal in principal, but said it could contribute to illegal activity if the information is misleading and causes harm.
“If these ghostwritten publications are contributing to the harm of patients because they’re making false claims, then that’s illegal,” McHenry said.
Articles from the company’s program appeared in five journals between 2000 and 2002, including the American Journal of Psychiatry and the Journal of the American Academy of Child and Adolescent Psychiatry.
Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective.
Publication in a medical journal also is a point of prestige for physicians, a fact Glaxo’s memo seems to acknowledge: “Physicians will be eager to participate in CASPPER regardless of their professional stature,” the brief notes.
Click here for the full report from ABC News
Antidepressant Use Doubles in U.S.
August 3, 2009
Reuters AlertNet
By Maggie Fox
Use of antidepressant drugs in the United States doubled between 1996 and 2005, probably because of a mix of factors, researchers reported on Monday.
About 6 percent of people were prescribed an antidepressant in 1996 — 13 million people. This rose to more than 10 percent or 27 million people by 2005, the researchers found.
“Significant increases in antidepressant use were evident across all sociodemographic groups examined, except African Americans,” Dr. Mark Olfson of Columbia University in New York and Steven Marcus of the University of Pennsylvania in Philadelphia wrote in the Archives of General Psychiatry.
“Not only are more U.S. residents being treated with antidepressants, but also those who are being treated are receiving more antidepressant prescriptions,” they added.
More than 164 million prescriptions were written in 2008 for antidepressants, totaling $9.6 billion in U.S. sales, according to IMS Health.
Drugs that affect the brain chemical serotonin like GlaxoSmithKline’s <GSK.L> Paxil, known generically as paroxetine, and Eli Lilly and Co’s <LLY.N> Prozac, known generically as fluoxetine, are the most commonly prescribed class of antidepressant. But the study found the effect in all classes of the drugs.
Olfson and Marcus looked at the Medical Expenditure Panel Surveys done by the U.S. Agency for Healthcare Research and Quality, involving more than 50,000 people in 1996 and 2005.
“During this period, individuals treated with antidepressants became more likely to also receive treatment with antipsychotic medications and less likely to undergo psychotherapy,” they wrote.
Click here for the full report from Reuters AlertNet.
Was Michael Jackson Chemically Manipulated for Profit?
June 29, 2009
NaturalNews.com
by Mike Adams
Anyone in a position of notoriety is automatically deemed a fair target for outrageous accusations and slander. As somewhat of a minor celebrity (in a narrow field) myself, I’ve seen some of this cruelty directed my way, and I can only imagine how much more devastating the cruelty would be at the scale and degree that was thrust upon Michael Jackson throughout his professional career.
Jackson was derided simply for being different. He had unconventional tastes and pursued uncommon lifestyle choices, and many of those choices made conservative people nervous. So they invented lies and played them up for their own personal profit. The whole accusation of Michael Jackson having sexual escapades with young boys was, by any honest accounting, a complete fabrication engineered for nothing more than personal profit.
In fact, Jackson was financially exploited by virtually everyone close to him. His “handlers” were highly-paid promoters who saw Jackson as their ticket to wealth. It might even be argued that they pushed him to the fringe of a pharmaceutical-induced death through their attempts to exploit his work for their own profits.
Again, I sometimes feel exploited in the same way, such as when companies pressure me to write articles about their products even though I’m on a hectic schedule of trying to cover other important topics. With Michael Jackson, though, the pressure must have been a thousand times worse. Hundreds of millions of dollars were on the line, and if Jackson could only be pumped up with enough drugs and makeup to bang out another fifty concerts, the people around him could walk home filthy rich.
Pharmaceuticals as tools of control
In the end, there’s no doubt that Jackson was pumped full of too many drugs for any man to bear. Pharmaceuticals don’t cure anything, after all, and the more you take, the more toxic the combinations become. The Sun newspaper in the UK claims Jackson was taking Xanax, Prilosec, Vicodin, Paxil, Demerol, Soma, Dilaudid and Zoloft. That’s an extremely toxic combination of drugs that no person should be taking long-term. And yet it seems (from press reports, if you can believe those) that Jackson was on some of these drugs for a very long period of time… decades, in some cases.
Certainly, Jackson himself is not free from responsibility in all this. His seemingly fanatical pursuit of cosmetic surgery might be called a form of self-inflicted medical abuse. Some of the drugs he was taking were no doubt pursued as a way to alleviate the possible pain and scarring resulting from so many surgical procedures. And yet for that, he can only blame himself, as those procedures were voluntary (and entirely unnecessary). Jackson was loved for his voice, his message and his wide-open heart. In no way did he actually need a new face to be a successful, inspiring artist (the face he was born with would have been just fine).
Being really famous leads to extreme isolation
While he may have made many poor decisions in his life (and with his health), in no way did Jackson deserve to be killed by Big Pharma. Nor does anyone else deserve such a devastating fate. Yet that same fate continues to hammer down upon a hundred thousand Americans each and every year. Their tombstones are not as elaborate as Michael Jackson’s, nor are their funerals as extravagant, but their deaths are just as tragic and unnecessary as the death of the King of Pop.
May he rest in peace, and may the cruel defamation of his character finally be laid to rest at the same time.
Click here to read the full report from NaturalNews.com
Emory Psychiatrist Draws Fire for Payments From Glaxo
‘Researcher’ found antidepressants like Paxil safe for pregnant & breast-feeding women
June 10, 2009
Wall Street Journal
by David Armstrong
More details are coming out about the relationship between Emory University psychiatrist Zachary Stowe and GlaxoSmithKline, which made payments to Stowe at the same time he was conducting federal research about the use of antipressants, such as Glaxo’s Paxil, in pregnant women.
Emory has reprimanded Stowe, who was instructed to immediately eliminate conflicts related to current federal grants. In a statement, the school said Stowe had informed it of “previously unreported activities and has disclosed his failure to abide by Emory policies.” Stowe, through the university, declined an interview request.
In a letter this month to Emory, Sen. Charles Grassley said records he obtained from Glaxo indicated Stowe was paid $154,400 by the drug company in 2007 and $99,300 during the first 10 months of 2008. Stowe is listed as the primary investigator on at least three National Institutes of Health grants, beginning in 2003 and continuing through last year, that involve antidepressant use in pregnant women and the effects on children delivered by those women.
Meanwhile, Stowe outlined some dealings with Glaxo in a deposition last year taken as part of a lawsuit claiming that Paxil isn’t safe for pregnant women. Stowe was questioned in detail about a 2000 email from an outside public-relations firm to a marketing executive at Glaxo about a planned press release for a new study. The study, conducted by Stowe, found Paxil is safe for breast-feeding mothers. The PR firm’s email to Glaxo reads:
Please review the attached press release and forward me any comments/edits. As you may know, Dr. Stowe is on board for publicity efforts and Sherri and I are coordinating time to meet with him next week to arm him with key messages for this announcement, which is slated for early February. We are sending the release for his review at the same time in efforts to secure distribution on Emory letterhead (as you know, would provide further credibility to data for the media).
In the deposition, Stowe said the quotes in the press release were his own. “They wrote it, we said it,” Stowe said of the involvement of the public-relations agency. As for the assertion by the PR official that Stowe was being provided with “key messages,” the psychiatrist called that “just typical public relations crap” and he said in the deposition he never received help from the PR officials.
