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?

Psychiatrist indicted for fraud in Paxil trials

NEW ORLEANS — Dr. Maria Carmen Palazzo was indicted by a federal grand jury on 55 counts of health care fraud and false documentation in connection with a clinical trial of Paxil in children and adolescents, U.S. Attorney Jim Letten said on Thursday.

The indictment alleges that during approximately a five-year period, Palazzo, 55, of New Orleans, defrauded Medicare in connection with services she claimed to have rendered to patients in a Psychiatric Partial Hospitalization Program at Touro Infirmary.

The indictment also charges that Palazzo defrauded Medicare by submitting fraudulent invoices to Touro for consulting and medical director services. The indictment says because of that Medicare paid Palazzo over $653,000 she was not entitled to receive.

Palazzo, who specializes in psychiatry, is also charged with offenses relating to clinical trials involving Paxil.
According to the indictment, Palazzo, as a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline, fraudulently failed to maintain and prepare records required by the FDA for evaluation the drug’s safety and effectiveness in children and adolescents.

If convicted, Palazzo faces a maximum term of 445 years, and a fine of $10.15 million, Letten’s office said.

Avandia Hearing Exposes FDA as Negligent Watchdog

Evelyn Pringle weighs in with the definitive (to date) piece on the Avandia scandal. Her entire article can be read here.

“The FDA has ignored repeated warnings about the potential cardiac risks associated with the diabetes drug Avandia, and medical experts predict Americans will likely pay a heavy price for trusting its negligent watchdog because US doctors wrote 13 million Avandia prescriptions in 2006 alone, according to IMS Health a medical information tracking firm.

On May 21, 2007, the New England Journal of Medicine published a meta-analysis of the heart attack and death rates from 42 Avandia trials completed before or after drug approval, that showed a 43% excess incidence of heart attack in Avandia patients. Dr Steven Nissen, Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and Immediate Past-President of the American College of Cardiology, and statistician, Kathy Wolski, MPH conducted the study.

The very same day, the Chairman of the US House Energy and Commerce Committee’s Oversight Subcommittee, Representative Bart Stupak (D-Mich), stated, in essence, that the Avandia debacle was the last straw.

“The FDA is on notice,” he said in a statement, “that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs and poisonous foods.”

Will anything actually change I wonder?

The FDA in America and the MHRA in the UK are supposed to be the bodies that protect you and me from unsafe medication… however, their respective track records over the past 15-20 years have not been good. The failings in the regulatory and monitoring systems would seem to mirror the increasing influence of the drug companies within the FDA, the MHRA and the governments of both countries.

Good ol’ Marty Keller

Dr Aubrey Blumsohn at Scientific Misconduct has a new article about ‘Marty’ Keller (catch up with my previous post on Marty and his infamous involvement with Glaxo’s Study 329  here).

In his article, “The path of least resistance and the case of Professor Martin Keller”, Dr Blumsohn discovers that it seems as though you had better keep on the right side of Marty or it could prove damaging to your career.

There is also a series of posts over at Seroxat Sufferers if you want to find more Marty and his life and times – the first two are here and here.