And while we’re talking about Study 329 – here are some real Seroxat Secrets

I know it’s going over old ground, but I’m prompted to write this by the recent posts at Scientific Misconduct and Seroxat Sufferers about Marty Keller and Study 329.

Firstly we must go back to October 1998 to an internal, confidential SmithKline Beecham document about studies 329 and 377. In summary it says “… the data do not support a label claim for the treatment of Adolescent Depression… efficacy had not been demonstrated.”

Specifically about Study 329 “…the study failed to demonstrate a statistically significant difference from placebo on the primary efficacy measures.” In other words – it didn’t work.

About Study 377 we read “… failed demonstrate [sic] any separation of Seroxat/Paxil from placebo.” In other words – it didn’t work.

“Data from these 2 studies are insufficiently robust to support a label change and will therefore not be submitted to the regulatory authorities.”

Feel free to download a copy of this document and read the rest of the interesting conclusions (especially page 6) – SB internal

Now we move on to March 1999, to a fuller manuscript of Study 329 being prepared for publication. This was written by Sally K Laden but was attributed to Marty Keller, Neil Ryan and colleagues. (I believe this is what is known as ghostwriting).

Please download a copy of this manuscript – Sally/Marty draft 3

If you go page 4 you will see the conclusion reads “Paroxetine is a safe and effective treatment of major depressive disorder in the adolescent patient.”

You can see that Sally/Marty’s spin has quickly moved on from that of SmithKline Beecham only 5 months previously. In fact you might be forgiven for wondering how these two different conclusions could be reached from the same data…

Now on to March 2001 – internally at least SmithKline Beecham seem to have understood what the data from Study 329 really said. In an email to Cohn and Wolfe, the company said: “Originally we planned to do extensive media relations surrounding this study [329] until we viewed the results. essentially the study did not really show Paxil was effective in treating adolescent depression, which is not something we want to publicize.”

Download a copy here – SB to Cohn Wolfe

However, by August 2001 SmithKline Beecham Paxil Product Management was writing to all sales representatives selling paxil and telling them about Marty Keller’s “cutting edge, landmark study which was the first to compare efficacy of an SSRI and a TCA with placebo in the treatment of major depression in adolescents. Paxil demonstrates REMARKABLE Efficacy and Safety in the treatment of adolescent depression.”

Download this memo here – Sales reps memo

As I said none of this is new. The last Panorama programme, Secrets of the Drug Trials was where all of this first broke.

Just a thought – I wonder if this is the kind of data that the big pharma apologists would have us rely on?

10 Responses to “And while we’re talking about Study 329 – here are some real Seroxat Secrets”

  1. Matthew Holford Says:

    But let’s not forget that somebody had to publish it… And then, ignoring the gobsmacking nature of SKB/GSK’s volte face, regulators had to pretend that this was an isolated incident, and everything was OK, really, if we just refuse to grant a marketing authorization for kids. Astonishing incompetence, or corruption, it’s still difficult to tell which. If I were the MHRA, I’d have been up GSK’s arse with a microscope a long time ago (not the most pleasant of imagery, but you get my point, I imagine).

    Matt

  2. truthman30 Says:

    It seems GSK is now trying to enter the blogosphere ( I wonder why ?) …

    With the release of its new weight loss “wonderdrug” alli…
    I wonder how many years it will take before the truth about alli comes out…

    Official alli Blog : http://www.alliconnect.com/
    Unofficial alli Blog : http://alliconnect.wordpress.com/

    I’m personally amazed how GSK are allowed to practice as a trustworthy business with trustworthy products…

    Considering they have maimed , harmed and killed hundreds of thousands of people with their succession of defective and dangerous drugs…

    Myodil
    Paxil/Seroxat
    Avandia

    They simply cannot be trusted…

    I wonder how their new wonder drug “alli” will fare?…

    Apparantly there are already concerns about its supposed “effectiveness” …

    http://junkfoodscience.blogspot.com/2007/05/big-sendoff.html

    Here’s what one healthcare practitioner wrote by way of caution for those who might be tempted to take Alli, as well as for the rest of us:

    HOWEVER, and this is VERY important…you will LEAK orange foul-smelling oil from your tushy if you eat fatty foods! It will not clean with toilet paper, it will stain the toilet bowl until scrubbed with bleach, and it will leak THROUGH your pants uncontrollably, also staining your clothes (it is VERY hard to get out, even with bleach). This will happen only once to convince you to decrease your fat intake..lol. No fast food on this medicine, no greasy foods, no pizza especially. I don’t know why they don’t warn people about this. I am an ARNP who prescribed it to many patients, but I gave them the warning to be careful. Carry baby wipes, and an extra set of pants!! At least until you know how it will affect you. Sorry, but somebody needs to warn the public. I will be afraid to sit on a cloth seat (think theater) anywhere in public when this comes out! The leaking stain is 99% permanent (smell too!). Well good luck all dieters..and don’t say I didn’t warn you, lol.

    According to Dr. Susan Norris, M.D., of the Centers for Disease Control and Prevention, despite unimpressive weight losses, “gastrointestinal adverse effects (explosive diarrhea, fecal incontinence, abdominal cramping, anal leakage and oily discharge) were common.” Smelly, embarrassing accidents aren’t the main concerns about this drug among medical professionals, however. As we’ve reviewed, the clinical evidence for this, like all the popular diet drugs, is short-term and shows modest effectiveness and high drop-out rates. More importantly, it offers no clinical support for long-term benefits for actual health outcomes, such as cardiovascular disease or deaths. No diet pill to date has been able to demonstrate that.

    While the public is focused on the weight loss, such as it is, the significance of its primary side effect is underappreciated. It reduces the absorption of fats — which are critical for health — and also fat-soluble vitamins (A, D, E and K) and beta-carotene. Twelve percent of Xenical users become vitamin D deficient within 2 years, and vitamin E and beta-carotene deficiencies have been documented in 6 percent of those taking it, according to the company’s literature. If millions of Americans begin taking this pill, the numbers of those with vitamin deficiencies are expected to grow.

    Young people still growing, pregnant women, the elderly, and those with gastrointestinal and absorption problems are of special concern. Dietary guidelines, for example, recommend teenage boys get 100 grams of fat a day and girls around 73 grams, significantly more than is possible on Alli. While it’s supposed to be for adults, many healthcare professionals are concerned that the readily-available OTC pills will be abused by teens and eating disorder-prone young people who already don’t hesitate to resort to laxatives.

    And while vitamin supplements are recommended by GlaxoSmithKline, fat-soluble vitamin supplements are of limited value on low-fat diets. Vitamin A is important for growth, healthy bones and teeth, reproduction, vision, and healthy skin and mucous membranes. Vitamin D is critical for helping maintain bones and teeth, muscular strength, and more. Vitamin K is essential for normal blood clotting and bone health. Other concerns that have been raised about Alli include possible roles in kidney stones, hepatitis and precancerous changes in the colon.

  3. truthman30 Says:

    alli might cause colon cancer and precancerous lesions were found in studies with mice, and the FDA approved it as an OTC drug!….. Unreal…

    http://www.citizen.org/hot_issues/issue.cfm?ID=1638

    http://www.revolutionhealth.com/healthy-living/weight-management/weight-loss-options/diet-pills-supplements/doc-faceoff

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