AboutTrisha Torrey, Every Patient's Advocate Expertise When you want to learn more about your diagnosis, medical tests, prescription drugs, talking to your doctor, or just want to find credible and reliable health or medical information on the internet, I can help steer you in the right direction. I'm not a doctor, nor a medical professional. I'm a patient safety, consumerism and advocacy specialist who believes patients do themselves a favor by finding reliable information on the internet, then sharing it with their health care providers.
Experience I am a consultant in patient advocacy and consumerism. I'm a newspaper columnist, radio talk show host, seminar leader, and owner of two websites to help those who want to learn more about their diseases or conditions: diagKNOWsis.org and EveryPatientsAdvocate.com
Organizations
Publications EveryPatientsAdvocate.com, syracuse.com (Syracuse Post Standard -- daily newspaper)
Education/Credentials Bachelors and Masters degrees in education. Marketing consultant for 25 years. This work, however, stems from a misdiagnosis I suffered in 2004 when I was told I had a rare cancer. I was able to do the necessary research to prove I had no cancer at all.
Question QUESTION: Where can a patient with kidney disease obtain the results of clinical trials done in order to get the FDA approval of
the drug Prednisone (a steroid)? I want to evaluate the side effects and success rate of Prednisone before taking it?
Thank you.
Elizabeth
ANSWER: Elizabeth,
You asked a great question, and I didn't have a complete answer for you. So I checked in with two people I knew could help, including a scientist who formerly worked at the FDA, and here is what they told me:
One resource for clinical trials information is www.clinicaltrials.gov however, those will be only the current trials.
Older studies: The best place to start is to find the prescription drug labeling for predisone and take a look at that. Depending upon what disease is being treated, there may or not be information in the label on use of the drug for treatment in that disease. Also would be helpful to have the person talk with their physician since some of the stuff is fairly deep.They should talk with the physician especially if the drug is being used off-label, and to have a discussion about whether the potential benefits outweigh the potential risks. If the doctor does not want to talk about these things, get new doctor. It is a doctor's obligation to explain these issues to patients.
QUESTION: Trisha, thank you for answering my question. What do you
mean by prescription drug labeling? Is that the description of it in the package? It is definitely used for kidney disease and my husband has that. I want to know the success rate with the drug and get an idea according the patients in the clinical trials what were the most common side effects. I understand it is a severe drug, according to the Nephrologist. Thanks, again.
Sincerely,
Elizabeth
Answer Elizabeth,
I'm thinking you may have asked the wrong question to get to the information you need -- which means we then supplied the wrong answers.... So let's see if we can clear this up.
Clinical trial information would be used for a newer drug, one that didn't have a good track record in place already, meaning side effects, contraindications, etc would still be in the discovery phase.
So when you asked about clinical trials, we didn't supply the right answers because reviewing clinical trial results (even if you could get ahold of the old ones) would not be the easiest way for you to get the answers you seek.
Prednisone has been around for a long time, which means there are well documented side effects in the literature, and easily found in plenty of places. It has been used for kidney patients, too -- so, again -- plenty of public information from credible sources.
You've asked about success rates -- and that will probably be impossible to find. Since every patient is different, the best you can hope for is that they would not be using prednisone to treat kidney disease if they didn't believe there was a better chance it would work than it wouldn't.
If you have any questions about the information found at the links above, ask your nephrologist about it. If he balks at providing the information or doesn't like you asking questions then, by all means, get another opinion. You need to have confidence that your husband's choice of treatment is the best available for his situation.
In cases like your husband's, where he is being diagnosed with a life-long illness and will be put on a difficult drug regimen, I always recommend getting a second opinion anyway. Again, it helps with the confidence level which can go a long way toward its success rate, too.
Best of luck. Hope this is what you needed, Elizabeth.