Experimental Drug Therapies

This blog is designed to cover the current controversy regarding experimental drug therapies. New drugs that are developed must go through a safety process. However, there are "compassionate use" exceptions made for seriously ill patients when no other treatments are effective. As future nurses/health-care workers, we need to be educated on this issue to be able to keep up with advancing medical science to be better advocates for our patients.

We hope that by reading this blog, we can provide you information on both sides of the issue so that you can form your own opinion on the topic. We also invite you to participate in our discussion by commenting on any of the posts!

Cancer Drug Not used to Fight Cancer?

According to recent studies, about 120 million people will be affected by Alzheimer's by 2050 worldwide. This seems like a striking number of people who will not have short term memory.

Recent studies have yielded a potentially promising result in the use of a particular cancer drug. This particular drug is from compounds called HDAC inhibitors which allows the DNA to allow neurons to make new proteins. (Dotinga). This drug could potentially stop the progression of Alzheimer's Disease as well as reverse the effects.

This information has been proven in labs among mice but clinical trials aren't expected to commence for another 3-4 years. If the number of Alzheimer patients is steadily increasing then it would seem more prudent to begin clinical trials as quickly as possible. Now that researchers have a better understanding of how Alzheimer's Disease works the potential success of this treatment is very promising. The effects of Alzheimer's Disease is debilitating and is increasing the need for individual care for these patients. If the clinical trials are successful then the number of Alzheimer's patients could drastically be reduced and hopefully in the future the disease can be completely treatable.

It is very sad to see someone with Alzheimer's Disease because the effects of the disease affect those around them as well. Family members are nothing more than strangers to patients with Alzheimer's Disease and it is a very emotional time. It is hard to see someone live the rest of their life without being able to remember where they are or what is going on. It is a sad way to live. Hopefully these clinical trials begin very soon so that people will not have to be affected by this disease.

By Ryan Wencl

http://www.bio-medicine.org/- Latest biology and medical news/technology

Read More 3 comments | Posted by blogpharm

3 comments

Crystal Lopez on October 28, 2009

I completely agree with your statement! Clinical trials should be started as soon as possible. My grandmother, who helped raise me, had Alzheimer's Disease. It is extremely difficult to see someone so close to you not be able to recognize you from some stranger. She also had to be in a nursing home because the disease progressed where she needed supervision 24 hours a day. This is something the drug companies need to put all that money to use and get those trial studies going.
Sue Guinn on October 28, 2009

I agree with Crystal. I too had a family member that had Alzheimer's. We were able to keep my grandfather at home but many families can't afford that. The cost of Alzheimer's is devastating and with the baby boomer generation living longer their chances for getting Alzheimer's increase. It will be interesting to see if more drugs will pass the FDA's criteria for being"safe" when we have national health care and "the public" will be absorbing these costs.
I think there will be a whole different way of looking at the approval of drugs. At least I hope so!
Anonymous on November 01, 2009

how come in this article you are talking about the need to speed up clinical trials where with the H1N1 vaccines you are talking about the need to take their time. i know, this drug is more tested for patients with cancer but the rules do state that the testing needs to be done the same.

UTA Pharmacology

Authors

Max Flores, Stacie Guinn, Ryan Wencl

Experimental Drug Terminology

CONTROL GROUP: The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

DOUBLE-BLIND STUDY: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

DRUG-DRUG INTERACTION: A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

EXPERIMENTAL DRUG: A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition

INFORMED CONSENT: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

OFF-LABEL USE: A drug prescribed for conditions other than those approved by the FDA.

PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness

PLACEBO EFFECT: A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

RANDOMIZATION:A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participan.

SIDE EFFECTS:Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects

Experimental Drug Therapies

Cancer Drug Not used to Fight Cancer?

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