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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!

CBS News - H1N1 Experimental Drug


When I first heard about the swine flu I wrote it off as a fad disease like Mad Cow or Bird flu, but it is clear now that this is real and it is really affecting the general population. A coworker of mine is pregnant and she is going as far as to wearing a mask when working.

The H1N1 is a scary disease and has the whole population under its scare tactics. Of course there is a vaccination, but there is still some debate on the safety of it. But even if you do decide to get it what are the chances that you will be able to get your hands on it? According to the CDC (Center for Disease Control and Prevention) 11,282,200 H1N1 vaccinations where shipped out as of Oct. 21, but only 831,400 of that is going to Texas. That really isn't enough for Texas' 24,326,974 population, and as of Oct. 19 Dallas, Tarrant and Denton Counties only had a combined total of 1400 doses available which had priority to health care workers, pregnant women, young children and the elderly.

But what about the people who have the H1N1 virus, what should they do? Watch this News video and see what you think?


Watch CBS News Videos Online

I think that this drug shouldn't be put on the market to quickly just because it seems so sensational, but also you need to consider that if this works then we need to use it before the virus mutates.
By Stacie Guinn

Sources:

Brown, D. (2009). Flu Vaccine Panel Creates Priority List. Retrieved from http://www.washingtonpost.com/wp-dyn/content/article/2009/07/29/AR2009072903607.html


CBS News. (2009). Life-Saving H1N1 Drug Unavailable to Most. Retrieved from http://www.cbsnews.com/stories/2009/10/19/eveningnews/main5398999.shtml


CDC. (2009). 2009 H1N1 Influenza Vaccine Supply Status. Retrieved from http://www.cdc.gov/h1n1flu/vaccination/vaccinesupply.htm


Flu Trackers. (2009). North Texas Health Agencies Recieve H1N1 Vaccine. Retrieved http://www.flutrackers.com/forum/showthread.php?t=128955


U.S. Census Bureau. (2008) State and County Quick Facts. Retrieved from http://quickfacts.census.gov/qfd/states/48000.html

Read More 6 comments | Posted by blogpharm edit post

6 comments

  1. Sue Guinn, RN on October 29, 2009

    I just read an article in the Texas Nurses Association's news letter that relates to this. There is a push to require health care workers to get the vaccine. It is already manditory in New York state and many other states are thinking of making it manditory. I hope that the testing that was done will be enough.

     
  2. Sue Guinn, RN on October 29, 2009

    The video brings home the point that in some cases it should allow drugs to be used immediately. This drug is saving lives and has already been shown to be safe. I just hope that the government is stocking-up on this drug because we are just entering the flu season...without this drug it could be a "short winter" for many!

     
  3. Dave Hubbard on October 29, 2009

    Interesting that there is an antiviral drug out there that has had more human testing than the vaccine the government is promoting and yet the more seriously ill have to have their physicians beg for it in order to save their patients’ lives.
    Meanwhile the government says take our vaccine, especially if you are a child or pregnant and the vaccine hasn’t really been tested and it is just assumed safe because the same basic protocols have been followed in producing it as the normal seasonal flu vaccine.

     
  4. Casita Pena on October 29, 2009

    I was a little wary of the H1N1 vaccine until I heard an interview on NPR with Paul Offit, an infectious disease expert. It was very informative and cleared up some of the misconceptions about the vaccine - like the rumor that it had not been tested as much as the seasonal flu vaccine. The interview is here - I would stronghly suggest taking a listen: http://www.npr.org/templates/story/story.php?storyId=113734207
    As for Dave's comment - everything is NOT a conspiracy

     
  5. Ryan Bowyer on October 29, 2009

    It's hard to argue with saved lives. I'm all for sufficient testing of potentially dangerous drugs (That would be all of them...), but if it works, than cut some red tape and get it to people!
    It sounds like this drug is only used on patients who are on their deathbed already, why not try anything available? If I'm dieing, I don't care if the drug is FDA approved, I'll try anything.

     
  6. Anonymous on November 01, 2009

    I agree, while it is not a good thing to push these questionable, untested vaccines on into common use with patients i still feel that if it is a worst case scenario, if you are on your death bed, what could it hurt? of course i use to work for a pharmaceutical company and my opinion might be a little biased.

     


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UTA Pharmacology

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      Max Flores, Stacie Guinn, Ryan Wencl
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    Blog Archive

    • ▼  2009 (10)
      • ▼  October (10)
        • In Conclusion...
        • CBS News - H1N1 Experimental Drug
        • Considerations to experimental drug therapies
        • LIfe-threatening Drug Back on Market - Is it Worth...
        • Cancer Drug Not used to Fight Cancer?
        • Interview with an Experimental Drug Patient
        • “No seriously ill person should have to die merely...
        • How a Clinical Trial Works
        • Brief History of Experimental Drugs
        • Welcome!!!

    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

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