More PhRMA rubbish about CME – and this is good

Daniel Carlat – he of The Carlat Pyschiatry Blog – is well placed to comment on continuing medical education (CME) as he’s a Doctor himself.

He writes (read the whole article here):

Marjorie Powell, Esq., the head lawyer for PHRMA (Pharmaceutical Research and Manufacturers of America), has just made it official: your drug rep can’t buy you more than one glass of wine at the educational dinner meeting you attend. This pronouncement was made today at a Senate Hearing entitled “Paid to Prescribe? Exploring the Relationship Between Doctors and the Drug Industry.”

Senator Claire McCaskill (R., Missouri) elicited this embarrassing lie after she told a story about how her brother, who owns a restaurant, said that his biggest profits came from renting out a private room to pharmaceutical companies giving dinner programs for doctors. The amount of expensive wine consumed at these dinners was astonishing, said Senator McCaskill. How could PhRMA claim that this money is spent for medical education, she asked Ms. Powell, when it appears to be nothing more than a lobbying tactic?

In response, Ms. Powell attempted to deflect the question, but the Senator was relentless: “Do you pay for alcohol?” Finally, cornered, Ms. Powell fumblingly outlined the official policy of PhRMA: “Maybe one glass of wine,” she said, and she then admitted that any amount of wine was not ideal for promoting medical education, or for improving patient care. “Much better would be to provide some pizzas for the nurse practitioners, who are the ones seeing many of the patients,” she said.

I urge interested parties to watch the hearing via webcast, as I did. Unfortunately, I just tried the webcast link and it appears to be broken. The written testimony is available, however, and includes some interesting comments from Jerry Kassirer (former editor in chief of NEJM), Peter Lurie of Public Citizen, Gregory Rosenthal (a retinal specialist who describes a $5 billion treatment pushed by the retinal industry), and Rep. Sharon Treat of Maine.

And if you want to hear our own AMA’s bland party line, cue up the testimony of Robert Sade, the Chair of the AMA’s Council on Ethical and Judicial Affairs. This makes for great bedtime reading, since you won’t get too far before slow wave sleep kicks in. Poor Dr. Sade had nothing to say for himself. When Senator Herb Kohl, the Chairman of the Committee, asked Dr. Sade how he felt about Minnesota’s law requiring disclosure of drug company payments to physicians, he responded, “The analysis of that data is incomplete”, and that “the AMA will be developing a position on that soon.” Thanks for representing the ethics of America’s physicians, Dr. Sade!

CIA’s release of documents implicates drug industry

This is lifted straight from Peter Rost’s excellent blog – he’s said it all, I think:

CIA yesterday released some pretty amazing documents about an agency spying on everyone in a most un-american way and the New York Times wrote a front cover story with the headline Declassified CIA Archives Detail Illegal Activities.

But there was one section New York Time missed, which New Scientist picked up, and this excellent magazine writes:

“Go to page 416, and you will learn of a behavioural drug screened as part of “larger programme, in which the Agency had relations with commercial drug manufacturers, whereby they passed on drugs rejected because of unfavorable side effects”. Drugs deemed interesting were later tested on “volunteer members of the Armed forces”. The programme was apparently considered “defensive, in the sense that we would recognize certain behavior if similar materials were used against Americans”.

It’s the complicity of the pharmaceutical industry, passing on drugs known to be harmful, that I find most disturbing. Any ex-spooks or pharma executives care to comment?”

Innervate Ltd, Jim Thomson and the Centre for Mental Health

Hmmm. I’ve been looking into The European Alliance for Access to Safe Medicines once again… while considering this new organisation and what it may or may not stand for (we wait with baited breath) I think it might be useful to consider the genesis of another organisation that Jim Thomson is involved with – the Centre For Mental Health.

After leaving Depression Alliance, Jim worked with Innervate as its Sales and Marketing Director – but only for a short time and well, ‘not really’, as Jim himself has told me “I did not, as you say, leave DA suddenly. I wanted to move the organisation in one direction (that being to broaden its remit) and the Executive Committee did not. Nor do I work for Innervate. I did for a short time, while I was trying to establish the Centre for Mental Health”.

So the Centre for Mental Health is Jim’s baby and he was only using Innervate as a stepping stone in some way? Even though he was Sales and Marketing Director… sales and marketing – Director? Not exactly a short-term role in my experience, but anyhow…

I’m sure you remember that Innervate has a track record of working to establish ‘patient organisations’, ‘forums’ and ’societies’. Its work with the Diabetes Monitoring Forum is a fine example of what Innervate can do – read more here and here.

Neil Bindemann, MD of Innervate is proud of his work and told a meeting of Harley Street doctors how he has “developed a specialist interest in establishing and developing communities of interest in support of the wider communication interests of his clients.” In the same round table table forum, he went on to describe his experience in founding and developing clinical associations such as the Primary Care Neurology Society and the Centre for Mental Health.

I’m getting confused now.

So Innervate established these “communities of interest” – the Diabetes Monitoring Forum, the Primary Care Neurology Society and the Centre for Mental Health – in support of the wider communication interests of its clients? Its clients being… various pharmaceutical companies?

And there was me thinking they were all grassroots patient groups…

So then, a few questions – in whose interests was the Centre for Mental Health established and developed and who paid for it?

And back to The European Alliance for Access to Safe Medicines – in whose interests has it been established, who is paying for it and who are Jim’s partners in this self-styled ‘Alliance’?

My collected posts about patient groups can be found here – be warned, there’s a lot to read!

And remember what Jim himself says “…ask yourself one question… What does this person, or this organisation, have to gain from taking this position?”

Pfizer and its lipitor study – lies or statistical error?

I see that Pfizer has been hiding negative data about Lipitor – thanks to CL Pysch (and Ed Silverman at Pharmalot who was first on the case with this story way back on 14 June!)

Pfizer conducted a study comparing Lipitor to Zocor and found positive results. Naturally, a favorable press release was issued, which opened by stating…

A retrospective analysis of a large U.S. managed care database showed that patients who took Pfizer’s cholesterol-lowering medicine Lipitor® (atorvastatin calcium) Tablets had a significant 14 percent reduction in the risk of cardiovascular events, including heart attacks and strokes, compared with patients who took simvastatin.

An “independent” academic was also featured in the press release, stating…

“This analysis is important for physicians, employers and formulary directors at managed care companies who are making real-world treatment decisions for patients,” said Dr. Robert Vogel, an author of the study and professor of medicine at the University of Maryland. “This further supports the cardiovascular benefits previously seen with Lipitor.”

So far so good – another drug company producing positive research to sell one of its products and trumpeting the results through the press.

There’s only one slight problem… it turns out the analysis was wrong. The difference between Lipitor and Zocor was not statistically significant – someone made an error during data analysis.

So what does Pfizer do – issue another press release to correct its lie (sorry, statistical error)?

Or maybe just quietly release the less favorable data analysis and not make a fuss?

Hmmm. Tough choice.

The answer is here.

Glaxo spends $2.4 billion on advertising – in the USA alone

GlaxoSmithKline was America’s seventh-largest consumer advertiser in 2006, according to TNS Media Intelligence’s Stradegy as reported in Advertising Age.With ad spend of $2.4 billion, GSK placed just behind Ford and ahead of Walt Disney, moving up from ninth-largest in 2005. J&J, last year’s No. 4 advertiser, slipped in the ranking to place ninth – still beating out the likes of Unilever, Toyota and Sony. Further down the list were clustered Pfizer, at 31, with $1.1 billion in ad spend, and Wyeth (33), Novartis (36), Merck (38), AstraZeneca (40) and Schering-Plough (42), all in the neighborhood of $1 billion.
The survey covered TV, magazine, newspaper, outdoor, radio and internet advertising. Perennial No. 1 P&G weighed in at $4.8 billion in measured media.

You’ve got to think that if Glaxo spent some of their advertising budget on research and development, then maybe it might discover some new drugs that were actually safe and effective…

Paxil, Prozac and SSRI Induced Suicide – Jeffery Dach MD

Dr Dach writes:

According to Irving Kirsch in Prevention & Treatment , “there is now unanimous agreement that the mean difference between response to antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents. The small difference between the drug response and the placebo response has been a “dirty little secret”. It was not known to the general public, depressed patients, or even their physicians”(link).

Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:

1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)

2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.

3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.

4) Miscoding suicidal events as “emotional lability”, and homicidal events as “aggression” to hide suicidal events from regulators.

5) False attribution of suicide to the placebo arm.

6) Hiring ghost writers to make the medical articles more favorable.

7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.

Using these and other gimmicks, the drug industry managed to gain FDA approval for the SSRI class of drugs. Since the FDA approval is the foundation of our medical system, the first step in restoring integrity is to halt the “waiver system” which gives doctors immunity from prosecution for conflicts of interest. The system allows doctors to deliberate on FDA advisory committees while receiving money from the drug industry, a conflict of interest that is also a federal crime (link)(link).

You can read the whole article here.