ANTI DEPRESSANT DRUG BLOG

BBC to Air ‘Secrets of the Drug Trials’ on Panorama

January 29, 2007

Documents Reveal Academic “Thought Leaders” Hired by Drug Maker
Promoted Paxil for Children and Adolescents Despite Clinical Trials
Showing the Drug Was Ineffective and Unsafe

January 29, 2007, 8:30 p.m. GMT
(In the United States via the Internet:
12:30 p.m. PST; 2:30 p.m. CST; 3:30 p.m. EST)

On Monday, January 29, 2007, BBC-One will air “Secrets of the Drug Trials,” a program detailing the investigation by reporter Shelley Jofre, which reveals how “one of Britain’s biggest drug companies misled doctors into prescribing the antidepressant Seroxat (known as Paxil in the US) to teenagers, even after one of its own clinical trials indicated that they were more likely to become suicidal after taking it.” This program is Panorama’s third in a series involving the selective serotonin reuptake inhibitor (SSRI) Paxil. http://www.bbc.co.uk/bbcone/listings/programme.shtml?day=monday&service_id=4165&filename=20070129/20070129_2030_4223_21585_30

The BBC program touches on a number of important issues, such as:

Academics serving as spokespersons for the pharmaceutical industry;

Medical journal articles ghostwritten by PR companies working for industry
and academics lending their names to the process;

Promotion of drugs as more effective than they are, while downplaying side effects.

See the British Medical Journal’s review of the program: “Inside big pharma’s box of tricks.”

Ms. Jofre’s October 2002 program “The Secrets of Seroxat” launched a firestorm of controversy and generated an unprecedented 65,000 telephone calls and emails to BBC in response. British regulators thereafter appointed a panel of experts to examine Paxil studies for treatment emergent suicidal behavior.

On June 10, 2003, the regulators announced that a review of the Paxil studies showed that the drug failed to demonstrate efficacy and showed “an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behavior in the [Paxil] group compared to placebo.” Six months later, on December 10, 2003, U.K. regulators announced they would contra-indicate the use of most antidepressants in children and adolescents in the UK. The US FDA followed suit the following year, in 2004, instructing manufacturers of antidepressants to include a “black box” warning regarding the increased risk of suicidality in children and adolescents.

Many of the documents in the BBC’s upcoming program were obtained through a consumer fraud class action lawsuit filed by Baum Hedlund. The lawsuit, which is pending in a California court, was filed on June 21, 2004 against Paxil’s maker, GlaxoSmithKline (GSK) alleging the company suppressed evidence of Paxil’s failed efficacy and increased risk of suicidality in children and adolescents.

For the past two and a half years, Baum Hedlund has amassed and reviewed hundreds of thousands of pages of documents and taken numerous depositions of GSK employees and academic “thought leaders” hired by GSK to promote Paxil. Although virtually every document produced by GSK is stamped “confidential,” Baum Hedlund attorneys were able to get some of the documents out from under confidentiality seal by court order or by getting GSK to concede that the documents were not properly labeled confidential trade secrets to begin with.

About Baum Hedlund:

Baum Hedlund has the longest track-record handling SSRI antidepressant litigation having litigated over 3,000 antidepressant cases in the past 16 years. Karen Barth Menzies, Baum Hedlund partner, has been at the forefront of the SSRI-antidepressant litigation for more than a decade. She is currently the lead attorney on dozens of Paxil suicide cases and antidepressant birth defect cases. Karen and her firm have successfully defeated preemption arguments in a number of cases, including Motus v. Pfizer and Witczak v. Pfizer. Ms. Barth Menzies has testified three times before the FDA and also before the California State Senate regarding the risk of suicide in children, adolescents and adults taking antidepressants. In 2004 Karen was awarded Lawyer of the Year by Lawyer’s Weekly USA and California Lawyer of the Year by California Lawyer magazine. In 2005 she was named one of The National Law Journal’s Top 40 Under 40 and in 2006 she was named Consumer Attorney of the Year Finalist by Consumer Attorneys of California. She is the author of many articles related to SSRI antidepressants.

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Wyeth drug could end up with dual role

January 22, 2007

Wyeth Pharmaceuticals is ex pected to receive initial approval next week for a new antidepres sant, but analysts say the drug’s greatest market potential could be among menopausal women seeking an alternative to hormone replacement therapy.

A spokesperson for Wyeth said the company expects the Food and Drug Administration to tentatively approve Pristiq as a treatment for major depression, though the company will likely need to submit additional information to get the final okay.

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Wyeth says Pristiq is a superior antidepressant to others already on the market because it helps manage two key hormones that affect a patient’s mood. The balance of these two hormones, Wyeth says, is particularly important in depressed women going through menopause. The most commonly prescribed medications only address the hor mone serotonin; Pristiq also acts on norepinephrine.

Pristiq is a key product for Wyeth going forward because the company’s blockbuster depression drug Effexor loses patent protection in 2010. Effexor was the No. 1 depression medication worldwide in 2005, with sales of $3.46 billion, nearly 20 percent of Wyeth’s total revenue.

Sales of Pfizer’s Zoloft, the top- selling antidepressant in the United States in 2005, plunged more than 40 percent in the third quarter of 2006 after the company lost its patent. Other leading antidepressants include Eli Lilly’s Cym balta and GlaxoSmithKline’s Paxil.

Pristiq is unlikely to expand Wyeth’s depression franchise, but it “will be used to capture Effexor patients before the latter’s patent ex pires,” Sanford C. Bernstein analyst Richard Evans said in a research note.

But even if Wyeth can successfully transfer patients from Effexor to Pristiq, the drug will enter an antidepressant market that seems to have passed its peak. Spending on antidepressants actually fell 4 percent last year amid concerns that the drugs increase risk of suicidal behavior in children.

With the market for antidepres sants saturated, Wyeth is looking to steer Pristiq toward an alternative use that shows more financial promise: treating menopausal symptoms.

FDA is scheduled to issue a decision on Pristiq for menopause in April. While regulatory approval is never a certainty, Leerink Swann analyst Seamus Fernandez writes last month that the agency will likely see Pristiq for menopause as “a compelling indication, given that there is a significant unmet need.”

Roughly 40 million U.S. women experience hot flashes and night sweats as a result of lower estrogen levels that come with menopause.

Harvard University professor JoAnn Manson said studies have shown antidepressants can be somewhat effective for treating me nopausal symptoms, and some doctors have already begun prescribing them off-label. A drug is used off-label when it is prescribed for a use other than the one authorized by government regulators.

“I would say there is a strong need for non-hormonal options be cause we know one in five women going through menopause have severe hot flashes that impair their quality of life,” Manson said. “They are looking for a therapy that doesn’t pose the risks of hormone replacement.”

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