Who runs the FDA? And what are the rules for approving new drugs?

by on March 26, 2011 · 5 comments

in Health, The Widder Curry

I could hardly believe what I was reading in the San Diego Union on Saturday, March 26, 2011. Across 5 columns was the headline, “FDA OKS FIRST MELANOMA DRUG THAT EXTENDS LIFE.”  I couldn’t help but wonder what my husband’s oncologist would say about that headline.

The drug is known as “Ipilimumab” and will be marketed under the name of “Yervoy.”  Let me tell you about my experience with this drug.

“Ipi”, as it was called when my husband was on a clinical trial to see if the drug would help his lung cancer, may have, in fact, cut months from his life.  He suffered every possible allergy from this drug. So much so, that the pharmaceutical company promoting the drug suggested that he be taken off of it after only two treatments.  He suffered shortness of breath; hot flashes; a rash that extended from the top of his head to the bottom of his feet. A rash so severe that he needed to be drugged to stop the terrible itching that invaded his entire body.  His skin turned the color of a matador’s cape, and there was no end in sight.

OK, you say, that was a clinical trial for lung cancer, not Melanoma.  And, you are right.

A few months ago, I stopped in the oncologist’s office to say hello and drop off a jar of jam.  The physician, who was usually happy, smiling, and positive was in a deep depression. (My diagnosis.)  When I asked him what was wrong, he looked at me, with tears in his eyes, and asked me if I remembered the drug “Ipi?”  How could I possible forget it?  He told me that he had been at the hospital all night because he had a female patient that had melanoma and she had been administered the same drug. I thought that Bob had it bad.  She began bleeding internally; they could not stop it, and had to have surgery to repair the damage from the drug.  She had been in the hospital SIX weeks! and at that point, he did not know if she would make it or not.   This from the very same drug that the FDA has now approved for the very same disease.

Bristol-Meyers stands to make a tremendous amount of money on this drug. They say that the cost of the treatment, per person, will be about $120,000!  Sixty-eight thousand people were diagnosed with melanoma last year, and 8700 of those people died.  People that were in the clinical trial for melanoma lived about 10 months compared to those on a placebo that lived 6.4 months.  That may be true, but I can’t help but wonder about the quality of life for those 10 “monthers.”  If it helped only 20% of the patients on the drug compared to 13.7% of the control group, I think I would take my chances of living a better life without the drug.   I’ve seen the drug in action. I don’t want it.

Oh yeah, by the way, I have an 11:00am appointment on Monday to have two skin cancers removed.  Diagnosed skin cancers from the biopsies taken last week.

Just what are the rules of the FDA when it comes to approving new drugs?

{ 5 comments… read them below or add one }

tj March 27, 2011 at 8:08 am

They are tools of Wall Street & Corporate America, like most of “our” politicians.


JChristian March 28, 2011 at 8:58 am

Another illustration of the Golden Rule: The one with the gold makes the rules.
Dear Judi, thanks for sharing.


RB March 28, 2011 at 10:52 am

While I don’t know this drug, I do know that both life extension data and quality of life measures are used for drug approval. Drugs in clinical trials are given to patients, not part of the drug’s intended use, to collect quality of life data. Unpleasant side effects are noted in the clinical studies and changes in the dose and period and method of delivery are made based upon the study.


judi March 28, 2011 at 8:16 pm

Thanks, RB. I know that Bob’s quality of life went significantly downhill while and after using this drug. JC – I didn’t realize until your article that Midas really is the pharmaceutical companies in disguise. Thanks.


Zach on the side March 29, 2011 at 4:38 am

Maybe a good rule to go by – if you can’t figure out how
to pronounce the drug’s name, stay away!

I don’t think there are too many these days who don’t
know that FDA stands for BigPharma.


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