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Nov 21, 2009

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I am not too worried about this issue (safety of new drugs like dabigatran). If you have ever read the data that gets submitted to FDA for new drug approval, the statistics, the reviewer reports, the clinical pharmacology, animal pharmacology, toxicology, minutiae of clinical trial adverse event tables, it is quite incredible how much material they pore over. Of course, industry can distort trial findings and bury them, but they don't tend to do this where the FDA is concerned. Of the hundreds of drugs that have been approved over the past 20-30 years, only about a score of them have been withdrawn from market. And the recent reports over dabigatran combined with antiplatelets in the acute coronary syndrome population seem very reassuring.

Of course, we've been down this road before ... with ximelagatran.

I think the most critical issue in the evaluation of new drugs is post-market monitoring, which inexplicably has only been recognized as an important FDA empowerment recently. Obviously new things show up when the patients number in the millions rather than hundreds.
As for the behavior of the pharm companies, they are not alone. As a pathologist, I had to routinely deal with vendors of laboratory analytic instruments and reagents. They were equally clever at cherry picking research papers positive to their cause, while dropping caustic comments about their competitors.
I found myself developing the same attitude which you describe.

There is too much money at stake in Big Pharma for us to blithely trust that things like drug safety should be in the hands of the industry.

In the words of Dr. Marcia Angell, former editor-in-chief at the New England Journal of Medicine: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

As a heart attack survivor who now takes a fistfull of cardiac drugs every morning, I have no clue which of these meds were prescribed for me based on flawed trials, or tainted journal articles created by Big Pharma-funded medical ghostwriters and their physician/academic pals who fraudulently claim to be the real authors, or the proven influence of industry-paid 'thought leaders' who are schilling drugs to their MD colleagues through pharma-funded speakers bureau and CME training - AND NEITHER DO MY DOCTORS.

The FDA is not in the business of policing "post-market monitoring" so that's not going to happen any time soon - or soon enough to help protect me or millions of other unsuspecting patients, as well as our docs who rely on their drug reps for an astonishingly large percentage of their pharmaceutical education.

As you say, Dr. Rind: drug companies who are "running parallel studies of an agent and then only publishing the positive studies while burying the negative studies" are hardly trustworthy. Why do medical professionals not believe, as patients do, that this is criminal behaviour putting millions of us at risk, and should be aggressively prosecuted? Remember Merck's "Australasian Journal of Bone & Joint Medicine" that looked and felt and smelled like a bona fide medical journal flogging Vioxx - but of course wasn't? Brilliant marketing - prepare to see much more of this fraud.


It's an extremely disturbing reality for all patients. A comment like the previous one: "...Recent reports...seem very reassuring.." is, sadly, a typical reaction from physicians. Drug companies are in the business of making sure that reports are 'reassuring', otherwise no docs would prescribe their drugs.

Stakes are very high in this multi-billion $ industry, and with several blockbuster drugs due to fall off the patent cliff by 2012, we can only expect to see an increasingly desperate explosion of Big Pharma's marketing strategies in ways we haven't even dreamed of yet.

Drug marketers are savvy and smart - we have to learn to outsmart them.

Carolyn Thomas
http://www.ethicalnag.org


Enjoying the blog Dr Rind! The final paragraph of this post nicely sums up the anxieties we all have about novel pharmacotherapies. Well done.

Great post, and can't agree more. I plan on talking about some similar topics in some upcoming posts as well. Great new blog, too!

Oooh yes I think you need these. We bin busy. :)

http://www.whp-apsf.ca/pdf/statinsEvidenceCaution.pdf

http://www.whp-apsf.ca/pdf/Evidence%20for%20Caution%20-%20
Facts%20to%20Act%20On.pdf

Both from: Women and Health Protection http://www.whp-apsf.ca/en/index.html

I'm liking this blog already. Good work.

thought you might find another post re: RE-LY by another evidence based blogger interesting, if you haven't read it already:

http://medicalevidence.blogspot.com/2009/09/unreliable-design-of-re-ly-trial-of.html

cheers,

pcb

pcb, thanks for the interesting link. Although I think Dr. Aberegg is right in general about the ways Pharma plays with noninferiority intervals in drug trials, I'm not so concerned about this particular issue in RE-LY. I'll likely post about noninferiority designs down the road....

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