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Jayveonia Harrison
Professor Stalbird
English Composition 1201-N01
April 11, 2016
Should Terminally Ill Patients Have Access To Experimental Drugs?
Have you ever went to Las Vegas and gambled? Well that is what life is like, a gamble.
Taking a risk and trying something new, but what happens when the risk doesnt go as planned?
Something like experimental drugs. This is why the access of experimental drugs should not be
approved because it is like gambling. You never know what the outcomes of experimental drugs
are; there could be benefits, complications, or a quicker death trap. Terminally ill patients
accessing experimental drugs are outweighed by the concerns and complexities. The concerns
are the experimental drugs have unknown side effects, there are limitations of availability, they
are costly, patients could lose hope, and the quality of life is at risk. The complexities are the
FDA could be sued and the experimental drugs phases could have a chance in not being
completed.
Access to experimental drugs does come with an expensive price to pay. Experimental
drugs are made in small amounts, meaning it can cost more for a larger amount. Terminally ill
patients can suffer unnecessary complications from experimental drugs that could bankrupt them
and their families in the process, although their life could be prolonged or possibly saved.
According to Joel B. Finkelstein in the article, FDA Clarifies Rules For Getting Experimental
Drugs, Ph.D. Frank Palumbo the director of drugs and public policy at the University Of

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Maryland School Of Pharmacy states, Many cancer regimens cost tens of thousands of dollars,
and health insurers and other payers are often hesitant to pay for any treatments that are
unproven. This means terminally ill patients would have to pay for experimental drugs out-ofpocket. Selling experimental drugs that are not effective could benefit pharmaceutical companies
because they will continue to make money off the drugs that doesnt help terminally ill patients.
However, the FDA has made a proposal stating drug manufactures can only charge the patient
what they had to pay to make the experimental drug, if the Right to Try Law is passed. The Right
to Try Law allows terminally ill patients to try experimental drugs that have passed phase one, it
is used in clinical trials, and the process has been approved by the FDA. This further explains
why terminally ill patients joined placebo groups that were voluntary. In the 1980s placebo
groups were used for AIDS patients, which consisted of placebo and experimental agents. AIDS
patients participating in these clinical trials may not have had a chance in being in the placebo
group, instead being placed in the experimental agent group, which they wouldnt have benefited
from. AIDS patients used the placebo group as a chance in receiving experimental drugs. Placebo
trails are still in effect for not only AIDS patients, but all terminally ill patients in need today.
Allowing access to experimental drugs could hinder the ability to rigorously study drugs
in clinical trials. Emily Waltz article titled, US Court Rules to Allow Experimental Drugs for
Dying Patients, the legal experts say, It could also eliminate the incentive for people to enroll
in clinical studies effectively slowing down the approval process. This means if experimental
drugs are approved, there is a chance that clinical trials wouldnt have anyone to test the drugs
they have created on, which would not help because there wouldnt be new experimental drugs
for the new generations of patients. This could be a disaster because post-phase one placebo

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clinical trials will be slowed down, possibly crossed out, phase two wouldnt show the efficacy,
and phase three would not be completed.
The FDA is taking all aspects of terminally ill patients using experimental drugs into
consideration before passing the Right to Try Law. Joel B. Finklstein in the article, FDA
Clarifies Rules for Getting Experimental Drugs, says the FDA has two goals to determine if
experimental drugs should be approved One goal is to enable many more patients who lack
satisfactory alternatives to have access to unapproved medicines while balancing the need for
safeguarding the individual patient. Another equally important goal is to ensure the continued
integrity of the scientific process that brings safe and effective drugs to the market. The FDA
does not want to release any experimental drugs that can potentially have a negative effect on
terminally ill patients because they could be sued for the complications of the drugs. The FDA
was sued before by the Abigail Alliance. Abagail Burroughs was twenty one years old with head
and neck cancer. The Abigail Alliance was created by Abigails dad Frank Burroughs; he created
this group because she passed away while entering the clinical study of Erbitux.
There is an extended application process for terminally ill patients, if the Right to Try
Law is passed. There has to be no other treatment options and the patient must have a
recommendation from a doctor. The Individual Patient Expanded Access Application would need
to be filled out; it could possibly take forty five minutes to be completed. Emergency phone
requests can be made. The patient must be reviewed by the Institutional Review Board or the
Ethics Committee to grantee that the risks are reasonable because the effects are unknown. The
patient doctor must later innate contact with the drug manufactures the doctor thinks is best for
the patient. This process would have to be done through the drug manufactures compassionate
use program director, to consider the patient the right to access experimental drugs. If the Right

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to Try Law is passed, completing this lengthy application process and having a chance to receive
experimental drugs could create false hope. The article by J. David Mcswane,Senate OKs Bill
to Allow Dying Patients Right to Try Untested Drugs, the State Senator Charles Schwertner of
the Senate Health and Human Services Committee says, One of the biggest tragedies is not only
selling hope, false hope, but also impoverishing them and their family with the non-judicious use
of pharmaceuticals in the last stages of their life. This could create false hope because if the
experimental drug doesnt work nor have a positive effect on the patient, the family and patient
will be disappointed.
However, there could be hope in allowing access to experimental drugs for terminally ill
patients. The patients lives could be saved or have a good enough outcome to hold off on the
patient dying. In John Tozzis article, Do Dying Patients Have a Right to try Experimental
drugs? Libertarians Say Yes, Victor Riches the Goldwater Institute Vice President of external
affairs says, These individual patients have a right to try a medication to try to save their own
life. The Right to Try Law has been signed in twenty five states, which means terminally ill
patients have a choice and right, the choice and right to control their treatment options that are
most effective for them and doctors. In the twenty five states, terminally ill patients have the
legal right to use experimental drugs before they could possibly be available on market in
months or years. Allowing access to experimental drugs could lead to new discoveries in
medications that could help prolong lives in the future. The patient has nothing to lose trying
experimental drugs, considering the fact that the patient already has a lethal illness. Patients will
be content and peaceful knowing that all options have been tried. The side effect of the
experimental drug could possibly make the patient more comfortable, and subside the pain. A
patient dying from a terminal illness that could possibility be treated or cured is devastating.

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There is further knowledge that can be gained from this experience, such as what can and cannot
work for the different terminal illnesses. The office of Special Health Issues (OSHI) discusses
the options by phone of experimental drugs or therapies that could help the terminally ill patient.
The OSHI cannot discuss experimental drugs that have not yet been approved. The OSHI has
long ago setup a website; the website provides information on public meetings, drug and device
approval, condition information, various treatment information, etc. This allows patients to stay
involved in the process of receiving access to experimental drugs.
Terminally ill patients quality of life could be decreased for the time that they have left,
without any added benefits from the experimental drugs. According to Juliana Hos article, A
Constitutional Right to Experimental Drugs states, While current policy could affect their
section seven rights, there is a clear societal interest in controlling the use of drugs that could
produce unpredictable or unmanageable side effects, and possibly death. Allowing access to
experimental drugs could possibly interfere with the section seven-charter rights; this protects a
persons right to life, liberty, and security. This could be interfered with because if the state
increases the risk of death by allowing experimental drugs that have unknown side effects to be
used, then right to life will be affected. The right to life can interfere with the right of terminally
ill patients using experimental drugs because it isnt consistent with the principles of the root of
justice. If the section seven-charter rights were violated, the government would have to explain
the limitations and logical viewpoint of how accessing experimental drugs could be a problem.
The court would have to justify if the standards could be maintained, and if the government
cannot, the section seven-charter rights would be violated.
In conclusion, the access of experimental drugs does have benefits, but they are
outweighed by the concerns and complexities. In order to access experimental drugs the lengthy

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application process would need to be completed. Terminally ill patients and their families will
have to pay for the expenses, the side effects are unknown and could be harmful. Experimental
drugs would not be rigorously studied because each phase wouldnt be completed. Accessing
experimental drugs could bring false hope to terminally ill patients, leaving them in distress. The
FDA could be sued for any difficulties of the experimental drugs.
Works Cited
Anderson, Monica. "Opinions on Expanding Access to Experimental Drugs Differ by Race,
Income." Pew Research Center RSS. N.p., 03 Mar. 2015. Web. 04 Apr. 2016.
Caplan, Arthur L. House-Bateman, Alison. Should patients in need be given access to
experimental drugs? Expert Opinion on Pharmacotherapy. N.p., 2015. Web. 14 Mar.
2016.
Finkelstein, Joel B. FDA Clarifies Rules for Getting Experimental Drugs. JNCI: Journal of
National Cancer Institute. N.p., 2007. Web. 14 Mar. 2016.
Friedman, Michael A. "Providing Access to Promising Therapies for Seriously Ill and Dying
Patients." Providing Access to Promising Therapies for Seriously Ill and Dying Patients.
N.p., 23 Jan. 2011. Web. 04 Apr. 2016.
Hellmann, Jessie. "Legislation to Let Terminally Ill People Try Experimental Drugs Is Debated."
Chicagotribune.com. N.p., 13 May 2014. Web. 14 Mar. 2016.
Ho, Juliana. A Constitutional Right to Experimental Drugs? University of Alberta. 7-14. N.p.,
07 Aug. 2015. Web. 14 Mar. 2016.

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Mcswane, David J. Senate OKs bill to allow dying patients right to try untested drugs. The
Austin American-Statesman. N.p, 9 April 2015. Web. 14 Mar. 2016.
Norton, Vicki G. Expanding Access to Experimental Drugs. Duane Morris Life Science Law.
N.p., 4 June
2015. Web. 14 Mar. 2016.
Radcliffe, Shawn. "Right to Try Movement Wants Terminally Ill to Get Experimental Drugs.
Healthlines RSS News. N.p., 8 June 2015. Web. 14 Mar. 2016.
Schklenk, Udo. "Should Dying Patients Have The Right To Access Experimental Treatments?
IFLScience. N.p., 13 Nov. 2014. Web. 14 Mar. 2016.
Tozzi, John. "Do Dying Patients Have a Right to Try Experimental Drugs? Libertarians Say
Yes." Bloomberg.com. N.p., 21 Aug. 2014. Web. 14 Mar. 2016.
Waltz, Emily. US Court Rules to Allow Experimental Drugs for Dying Patients. Nature
Medicine. N.p, 1 June 2006. Web. 14 Mar. 2016.