Monday, December 29, 2008

FDA/CDER "no answer" answer to my request about when Stellara will be approved

I just received my third FDA unhelpful response that can be summarized in real people speak in the following sentences: "Sorry we cannot help you." "We refuse to tell you when the NOVEL medication with "stunning" clinical trial results will be available to your son." "We only help pharma companies." "Real Americans can go sit and in a corner and die for all we care as long as our jobs are protected. "

But even more amazing is that after three of these FDA/CDER no help emails, FDA CDER sent me a customer satisfaction survey. Yes, they asked me how I felt about their "service."

What fun it was to fill out their survey! I know, I know, no one will read it, but somehow it was satisfying to write down what I felt. You can read my response to their survey at the end of this post.

But first I thought I would provide you with the pleasure of reading the FDACDER's third and most recent response. I wrote to them asking about the delay in approving the REVOLUTIONARY advance in the treatement of psoriasis namely Centocor's Stellara aka Ustekinumab aka CNTO 1275. (Ever wonder why all these new investigational meds have three names?)

The FDA/CDER email is in red and my translation is in blue.

Dear Mr. Welch,

Thank you for writing to the Division of Drug Information in the Center for Drug Evaluation and Research (CDER). Please note that under the Freedom of Information Act (FOIA), the U.S. Food and Drug Administration can only provide information on approved drug product applications. (We will only give you info on medications that are already approved and in your local pharmacy. Information that any internet search engine can find quicker and again ONLY information about Meds that a doctor can ALREADY prescribe. Meds NOW on the pharmacy shelf. Meds that Paul has tried that did him little or no good-some even harmed him --bloody hives, breathing shut down.) Any information on an application submitted by a firm to the FDA, that did not receive approval, belongs to the manufacturer/sponsor developing the drug (21 CFR 314.430) so this type of information is not available from the FDA. (We know, but we won't tell you. You, stupid parent, thinking you have any political pull or importance to anyone at the FDA. You should know that ordinary Americans without political and financial influence are of NO import to us.) However, you may wish to contact the manufacturer/sponsor directly to inquiry about this product -- including the status. The manufacturer/sponsor is the source that can provide you with information on its product. (We are pretending that the manufacturer would actually give you information. We know they will not but by saying "CAN PROVIDE" we make it appear that there is a way to get the information, but of course we know they will not and we do not care.)

In addition, there is a mechanism (Compassionate Use) to access products that have not been approved. However, this would involve a physician willing to file a single patient or emergency Investigational New Drug (IND) application and this must be done with the cooperation and permission of the drug supplier. (This is a hours or even days long mind numbing process of ridiculous paperwork put in place to protect FDA bureaucrats first and foremost with no thought to getting the med to patients in need in a timely manner. Furthermore most physicians have no knowledge of new drugs in the pipeline. So they are scared even annoyed to be asked. The application puts all the risk on the doctor. What doctor is going to accept the risk of losing his profession for one patient? Finally even if the doctor is some kind of saint, accepts the risk and spends the hours needed to comply with all demanded records (the patient's med records and the doctor's education and experience records) and fill out the data demanded by the FDA, the Pharma company HAS THE FINAL SAY. That is correct. The company developing the med can and always does say NO. NO. NO. NO. That is it. No appeal. When the pharma company says no, their "no" is absolute with no way out and no appeal. Not even the courts will let you have the med. Court case after court case gives one and only final say EXCLUSIVELY to the company EVEN WHEN THE PATIENT WILL DIE WITHOUT THE MED. That's right. You can have a life threatening infection and the only antibiotic that will save you is not yet FDA approved, then YOU DIE with NO ACCESS and no right to sue.) For more information accessing unapproved products and single patient/emergency IND, please visit the sites at and

Lastly, FDA has a role in facilitating appropriate treatment access to investigational drugs, while at the same time recognizing the need to protect the public by requiring that drugs are proven to be safe and effective before they may be generally marketed to US consumers. The agency is committed to making effective therapies available to patients in need and continues to offer access to unproven therapies through our special access programs (as explained above). (LIE! BIG FAT LIE!)

Sincerely, Division of Drug Information LL Center for Drug Evaluation and Research Food and Drug Administration (NOTICE there is no name. The monster and liar who wrote this was too ashamed to put his name on it.)

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. (More CYA babble by the coward who wrote the rest of this letter)

My response that I gave them for their satisfaction survey is reproduced below.

My son has been an un-oiled, frozen Tin Man like in own personal version of a Wizard of Oz horror for last four years. And for at least the last two years a medication to help him has been tied up by the FDA.

Don’t BS me about compassionate use. Compassionate Use is neither. There is no compassionate from pharma nor do they allow any use. We have tried for 18 months to get access. The answer always is NO. NO. NO!

Clinical trials are a scam. They are not run on scientific principles to get the best possible knowledge. No, they are narrowly set up to get skewed results in hopes of getting FDA approval. Exclusionary and inclusionary criteria are written to eliminate all risk or any event that might further delay the glacially slow FDA approval process. They are not set up to get good science.

Worse the sickest patients like my son who will be first in line when investigational drug is finally FDA approved are deliberately excluded from the clinical trials. My son has been excluded from TWO clinical trials because his symptoms were TOO severe. Clinical Trials as currently concocted give NO data on the truly sick for doctors to look at when prescribing.

When "stunning" breakthroughs with NOVEL medications in clinical trials do happen, you folks delay, delay, delay. Do you think it is humorous to contemplate all the suffering and tortured patients waiting and dying while you delay MAJOR BREAKTHROUGHS?

APPROVE USTEKINUMAB/STELLARA NOW! It has the potential to allow my son to move again. How long will you %$#&@@!! make my son sit in a wheel chair while you play protect your backside games.

If FDA Commissioner, Andrew C. von Eschenbach, did not want to do any work at the job of running the FDA, why did he take the job?

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