July 20, 2007:

Kidney cancer is a form of cancer where treatment options that were formerly quite limited is now undergoing a transformation. The last several years have seen the release of several new drugs targeted at slowing the progression of the disease though none have been proved to provide a complete remission like some of the other cancers.

Mom got two infusions of a brand new drug called Torisel that was just approved by the FDA (Food and Drug Administration) on May 31, 2007. We had to go through significant work to obtain it, but the point is that we did it. And we did it through the tremendous tenacity of mom's community oncologist. Here's the steps we followed.

1. Called the manufacturer and asked what the process was for a program called "compassionate release" - this program is for drugs that have been approved by the FDA as treatment for a specific condition, but aren't on the market yet. Essentially the patient's doctor has to prove through medical records and other things that the patient has exhausted all other treatment options and this drug is their last hope.

2. Gave the contact information and description of the process to mom's doctor.

3. Waited a week or so for the doctor to gather all the information. Helped by providing medical records, copies of scans and other reports. Provided to her the name of an expert we found who had worked on studying the drug so that he could answer some questions that she had.

4. Once the doctor prepared all the material, they submitted it to the manufacturer.

5. Once the manufacturer provided its approval to release the drug, the hospital's Investigational Review Board had to approve the drug for use in their hospital (this only took a day).

6. Mom's doctor and the research coordinator worked with the pharmacy and the nursing staff to make sure the most experienced people received and administered the drug.

Sadly, I heard many anecdotal stories of patients being told that the drug wasn't available yet and, therefore, wasn't an option. That is not necessarily true. If a patient thinks that this drug is what they need then they should have a very concrete conversation with their doctor about why this is or isn't an option from a clinical standpoint and not a convenience one.