Professional Documents
Culture Documents
Ballenger, Scott. Terminal Patients Should Be Allowed to Take Unapproved Medications. The
Opposing Viewpoints. Rpt. from Should Dying Patients Have a Right to Use
Nov. 2016. David Huntley was diagnosed with ALS or Lou Gehrigs disease. He was not
only a professor emeritus in the department of geological sciences at san diego state
university but also a marathoner, scuba diver, and an ironman triathlete. This illness
degrades muscle control, so for him it was very hard to not be active. There was an
experimental drug called GM604 which was under trials to be approved. the FDA
disapproved its use and he commented, Why is the FDA not letting me use a potentially
lifesaving drug?
Booth, William (English archbishop). FDA looks to speed up drug approval process. Science
241.4872 (1988): 1426. Opposing Viewpoints in Context. Web. 8 Nov. 2016. The FDA is
looking into speeding up the drug approval process for drugs that will save life
threatening diseases. Many AIDS patients are desperate for a drug that shows just the
slightest hint of efficacy. There are many critics like Jeff Levi from the National Gay and
Lesbian task force who are saying it is just a political exercise to boost the vice
presidents popularity. Also, Deborah Katz from the National Institute of Health, AIDS
department is saying no because most of the drugs they have tested have not worked for
this disease. Frank Young, the director at the FDA is saying that this is not to approve
promising drugs faster but potentially lifesaving drugs for uncured diseases.
Cha, Ariana Eunjung. The dark side of compassionate use of experimental drugs. Washington
Post 31 Aug. 2016. Opposing Viewpoints in Context. Web. 8 Nov. 2016. Experimental
drugs have their name for a reason, and the name explains the name, not fully tested.
though these drugs can save lives they can also take them away. A few years back there
was a campaign for saving Josh. He was infected after a bone marrow transplant. There
was a company that had a new drug Brincidofovir that many of Joshs doctors thought
would work. Even after repeated requests to the company for the drug Chimerix denied.
When his parents rallied their friends, they rallied their friends they got the whole
internets support. After a request, again they got the drug, and he got to go home after
being cured. But when another doctor was trying a different new drug on another patient,
Fry-Revere, Sigrid. Terminally Ill Patients Should Be Allowed to Use Experimental Drugs.
Prescription Drugs. Ed. Sylvia Engdahl. Detroit: Greenhaven Press, 2007. Current
Controversies. Rpt. from When Its Life or Death, Who Makes the Call? Los Angeles
Times 15 Aug. 2007. Opposing Viewpoints in Context. Web. 8 Nov. 2016. Patients have 2
options at the brink of death, die or try a risky experimental drug. When this case is
brought to court, the court says that it is better to die than have a chance at survival.
Patients should be able to weigh risks for themselves and not need the government to
decide for them. The only way for people to have a chance in getting the drug was to try
and get into one of the 2000 spots that may be available from the FDA that are taken in a
matter of minutes. After you lose your grip on life you lost it, even if the drug may have
346+. Opposing Viewpoints in Context. Web. 8 Nov. 2016. Should we listen to the
activists or science? This is the big question people are asking to try and figure out
whether cancer patients should get early access to drug. There is a cure but there is very
limited access to this combination of drugs that cancer patients are begging for. Now
back to the big question, who should we listen to? There is a chance that it will not work
and that is what people are worried about. But for some patients, the combination of
Olsen, Darcy. The Right to Try: How the Federal Government Prevents Americans from Getting
the Life-saving Treatments They Need. New York, Harper, an imprint of HarperCollins
Publishers, 2015. This book is a clever compilation of some of the most historic moments
in drug approval and history including Ted Harada, the first person to survive ALS and
have the symptoms reversed temporarily and slow the deterioration of patients with ALS
though the is no total cure this is the best chance of survival anyone can have with ALS.
It also includes a woman whose name was Jenn McNary, she had 2 children who both
had DMD or Duchenne Muscular Dystrophy, this disease is caused when a genetic code
is jumbled and a cell is not able to produce an exon, for example exon 51, by
implementing exon skipping which is a technique for removing the faulty part of the
genetic code and having the cell run the rest is a way of slowing the progression of the
disease and allowing the person to live longer, in this case Max and Austin, Jenns two
sons.
Premier Research. The Powerful and Evolving Role of Patient Advocacy Groups in Clinical
Research. Premier Research, digital ed., 2016, pp. 1-13. This source has information on patient
advocacy groups meeting with the FDA and their evolving role which is getting deeper and
deeper into the drug approval process. These groups are also supporting diseases called orphan
diseases which are rare and for drug companies not worth. It is not worth for the companies
because the customer amount is so little that the cost of buying one dose would be unbelievably
high, compared to making the same profit selling 10,000 cold and cough medication pills, as this
is the most common disease in the United States this amount is nothing compared to the market.
Through these patient advocacy groups there is now more funding for orphan drugs and the
number of proposals for orphan drugs is going through the roof with 354 drugs approved in 2015
compared to 1993 with 1 drug approved.