- With Mayo Clinic nurse educator
Sheryl M. Ness, R.N.
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Sheryl M. Ness, R.N.
Sheryl M. Ness
Sheryl Ness, R.N., O.C.N., is a nurse educator for the Cancer Education Program at Mayo Clinic in Rochester, Minn. She helps inform patients, families and caregivers about services and resources to help them through the cancer journey.
She has a master's degree in nursing from Augsburg College. In addition, she is an assistant professor of oncology at the College of Medicine, Mayo Clinic, and is certified as a specialist in oncology nursing. Sheryl has worked for more than 20 years at Mayo Clinic as an educator. She has a keen interest in the importance of the quality of life and concerns of people living with cancer.
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Living with cancer blog
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Sept. 1, 2012
Compassionate use of experimental drugs possible in cancer treatment
By Sheryl M. Ness, R.N.
Every week, new experimental drugs are in the news for cancer treatment. The process of studying and approving a new cancer drug from start to finish can take many years. In certain situations, the Food and Drug Administration (FDA) gives permission to companies to provide new experimental drugs to people outside of the clinical trial process. This is usually called compassionate use of a drug.
In order for you to receive the experimental drug with the compassionate use program, your doctor must contact the drug company as well as submit an application to the FDA. There are strict criteria that must be present in order for you to be approved.
- You have advanced cancer.
- You have used standard treatments and they have not worked for you.
- You aren't eligible for clinical trials using the experimental drug.
- You have no other treatment options available, and your doctor believes that you'd benefit from the experimental drug.
- The company that makes the drug agrees to provide it to you.
Keep in mind that even if you're approved to receive the experimental drug, you may experience unknown side effects and you may not benefit from treatment.
Also, not all drug companies agree to give access to experimental drugs through this process. Be informed about the costs — the drug company may charge you for the experimental drug and your insurance company may deny coverage of experimental drugs.
Another way to gain access to experimental treatments is to look for expanded access studies. To find studies, search for the term — expanded access studies — on ClinicalTrials.gov. For more information on the FDA process for compassionate use of drugs, visit the FDA website (www.fda.gov/Drugs/default.htm).
Follow me on Twitter at @SherylNess1. Join the discussion at #livingwithcancer.
5 comments posted
September 6, 2012 3:32 p.m.
You are very fortunate, Vicki, that the natural supplements have worked for you. But one does not generally die of roseacea (which I too have) or osteoarthritis (which I too have). And diabetes and heart disease can be controlled. I am 80 and have had metastatic breast cancer for 3 years. Without the drug treatments I have had, I would now be dead. I am careful about what I eat and exercise regularly. But natural treatments do not work for cancer. And natural treatments do not "cure" metastatic cancer. That is a wishful myth. There is no cure. Wish they did.
- Ethel
September 6, 2012 2:50 p.m.
Totally agree with Vicki
- Maryrose
September 6, 2012 1:07 p.m.
Many experimental drugs are part of double blind trials. Instead of randomly assigning people, is there a way to allow people to choose which arm they want to be in?
- Dileep
September 6, 2012 12:18 p.m.
If anyone really cared about curing cancer, and they don't because it is a multibillion dollar industry, they would also experiment with natural substances. Many people have been cured here in the USA and overseas, but no one cares, as Big Pharma rules the USA, and the FDA believes everything they say. It's so sad. Just look at all the lawsuits for killer drugs that have been released on to the public. It's big money for everyone involved in the medical field and the drug companies. The only losers are the patients. This is from someone who despises drug companies except for extremely rare occasions such as infections or major surgery. I have taken care of my own osteoarthritis, roseacea, diabetes, and heart problems and have survived so far to 75 years of age. The all natural supplements I started using about 25 years ago, and I research them constantly. If cancer were ever cured all the cancer clinics would have to be shut down and millions of people put out of work. So what is your incentive? I realize specific cures have to be addressed to specific cancers, but there are just as many natural substances out there that you don't have to get in bed with the drug companies, who test things for a year or two then the public spends the next half-dozen years finishing the testing and they don't get paid for doing the rest of the research. Instead, they fork out millions for stuff that is slowly killing them physically and financially. I intend to die naturally.
- Vicki
September 6, 2012 11:52 a.m.
Drugs take years to be accepted. Drugs have side effects. The research group from Johns Hopkins tell us the the present methods kill more than they heal yet have been in use for years already. When are we going to get real and properly look into treatments that do not lessen the bodies ability to fight for itself? The true cure for Cancer is to strengthen body, mind, and spirit to allow the client to heal themselves, and who knows the person better than they do themselves? I would be interested in the comments of others in this.
- Anthony
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