Interesting article in New York Times

Posted By
W.
9/19/2010 1:08pm
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W.
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Replies: 10

http://www.nytimes.com/2010/09/19/health/research/19trial.html?_r=3&partner=rss&emc=rss&pagewanted=all

It's about ethical problems with clinical trials, in this case PLX4032.

It's a LONG article, I have not read it completely yet.

Anonymous - (9/19/2010 - 1:27pm)

Great article. Thanks for posting it. This paragraph really says it all:

"But critics of the trials argue that the new science behind the drugs has eclipsed the old rules — and ethics — of testing them. They say that in some cases, drugs under development, PLX4032 among them, may be so much more effective than their predecessors that putting half the potential beneficiaries into a control group, and delaying access to the drug to thousands of other patients, causes needless suffering."

From the beginning, it has seemed to me that comparing PLX4032 (and others in the same category) to drugs like chemo, is not only cruel, but bad science and a waste of trial time. It is all too obvious which one is going to be most likely to extend life. There must be a way to change the trial process. I understand why trials have to be carved in stone, but why in this particular kind of stone?

This is REQUIRED READING!  We all need to be aware of the swirling scientific, political, ane economic pressures around the FDA currently.  Take a look at the Avastin and breast cancer situation.  Is it mere concidence that almost simutaneously with the FDA action on Avastin that Roche get lots of press regarding PLX 4032?  This is not to impugn any of the key players' motives, but we all need to recognize how the system works - both for and against patients.  Very good article - thanks for posting the link.

Jim

I recently looked at all the current melanoma trials. I have choosen to bypass any that have control arms. We have enough data where controls arms should not be required. The Pharma companies spend $100 million to get a drug to market but must follow the FDA procedures. We need more compassionate use trials. The FDA needs to change their rules.

Great article well written giving info with out choosing sides.

We should Let The FDA ,Congress and Plexikkon how us the Patients feel about the clinical trial protocols.

Peter HirthCEO Plexxikon
tkassberg@plexxikon.com
Tom Kassberg is cofounder

Richard Pazdur
Richard Padzur to run its new Office of Oncology Drug Products (OODP)
pazdurr@cder.fda.gov'

I received an email from Kathy Glaub, President of Plexxikon, asking me to provide more contact information here.  She said:

We would appreciate a correction to information posted on your message board.  If patients want more information about the drug and clinical testing, the best source is the Roche/Genentech call center at 888-62-6728, www.roche-trials.com, www.genetechclinicaltrials@druginfo.com, or www.clinicaltrials.gov.  

 

If you have trouble getting what you need feel free to contact me and I will put you in touch with Kathy directly.  I have never met her but she seems approachable.

 

Tim--MRF

That was depressing to read.  I definitely believe people should sign up for every clinical trial w/BRAF in it and if they get the control arm, just apply for another one.

Insert Generic Inspirational Motto Here

Great article.  Brought tears to my eyes.  I hate those trials where the control arm is "standard of Care".

I hope to be fortunate enough to get into a BRAF trial which does not have a control arm and the only difference between the 5 arms is the initial dosage for 15 days.  After that, all trial participants receive 960MG. Trial NCT01107418.

Praying for selection into the trial.  Praying that it helps in my particular situation.

Bill

Bill from Illinois
Stage IV Spine Mets, brain mets ans subq mets.
starting whole brain radiation on 11/8 and then compassionate use IPI ASAP.

We have that exact BRAF study in Omaha if you can't get into this study in your state. 

Definitely a moving and informative article; they seem to need to have such a dramatic situation (one cousin living, one dying) to have a narrative hook into the story. I can see the ethical issues and economic drivers . . . . but I wish the scientific argument for the double-blind were clarified, i.e. why you would need the control arm, since the "standard of care" is already a known entity. Why not just measure new results against known data?

If you have time to chatter
Read Books.
If if you have time to read
Walk in the mountains, desert and ocean
If you have time to walk
Sing song and dance
Sit quietly, you happy Lucky Idiot--Nanao Sakaki

Definitely a moving and informative article; they seem to need to have such a dramatic situation (one cousin living, one dying) to have a narrative hook into the story. I can see the ethical issues and economic drivers . . . . but I wish the scientific argument for the double-blind were clarified, i.e. why you would need the control arm, since the "standard of care" is already a known entity. Why not just measure new results against known data?

If you have time to chatter
Read Books.
If if you have time to read
Walk in the mountains, desert and ocean
If you have time to walk
Sing song and dance
Sit quietly, you happy Lucky Idiot--Nanao Sakaki