Differences in the use of various cancer treatments occur
between individual oncologists and medical institutions.
This variability can create tension between doctors in different medical disciplines, but can also motivate the entire field forward.
- Drug companies and other sponsors may be involved in researching and
advancing off-label use of specific treatments. Off-label use occurs when a
physician prescribes a medication for a condition other than the one for which
the FDA has given approval.
- Patient advocacy groups may have their own preferred treatment strategies.
The lack of consistency can be confusing for patients, but can also empower
them to search for them.
Patient Advocacy Groups
Patients involved in advocacy efforts work tenaciously and creatively to move the drug
development process forward to a shorter timeline and faster approval of safer, more
effective therapies.
- Patient advocacy groups often work with other stakeholders to represent the
patients' perspective in the drug development process.
- These groups may also partner with industry in clinical trial recruitment, patient
education about treatments, and other ways.
Patients
Cancer patients illustrate the obvious need to advance cancer research and inspire all stakeholders to work towards the
goal of safer, more effective therapies. With over 500,000 cancer patients around the
world dying annually, people with cancer clearly need better treatments now and
implore the system to create treatments that lead to life extension measured in years
instead of months.
Although researchers and clinical trial sponsors can
prepare the way for new drug development, without
patients who volunteer for clinical trials, the process
would stop.
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- Patients who are participants in clinical trials
require from doctors full disclosure and clear
communication using informed consent about the
potential risks and benefits of a drug under study.
- Treatment decisions made by people with cancer
illustrate their different priorities of quantity
versus quality of life. Other stakeholders must
factor in these variables and the range of needs of
patients.
- Patients are often overwhelmed by the cost of cancer drugs and seek assistance
from other stakeholders such as patient advocacy groups and direct programs
managed by drug companies.
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Patient access to unapproved drugs
Patients diagnosed with a terminal illness may pursue access to and treatment with
unapproved drugs. Cancer patients can apply for unapproved cancer drugs through
FDA programs- Expanded Access and Special Exemption/Compassionate Exemption.
- Tension exists between patients, advocates, and drug companies about when to
make drugs available to people with cancer. Groups may have differing views
concerning parameters of safety and access. This tension is unique to cancer
because of the urgency associated with survival statistics of many types of the
disease.
More information can be found in the NCI fact sheet:
Access to Investigational
Drugs
Drug Access: Direct Financial Assistance from Industry
Patients and their caregivers can contact the drug company that manufactures the
drug to which they want access. Doctors must be involved in completing application
forms.
Bristol-Myers Squibb Patient Assistance Foundation: 1-800-736-0003
http://www.bmspaf.org
Chronic Disease Fund: 1-877-968-7233
http://www.cdfund.org
Genentech's Single Point of Contact: 1-888-249-4918
http://www.spoconline.com
GlaxoSmithKline's Commitment to Access: 1-866-265-6491
http://www.commitmenttoaccess.gsk.com
Lilly Cares: 1-800-545-6962
http://www.lillycares.com
Partnership for Prescription Assistance: 1-888-477-2669
http://www.pparx.org
Patient Advocate Foundation's Co-Pay Relief: 1-866-512-3861
http://www.copays.org/
Pfizer's FirstRESOURCE: 1-877-744-5675
http://www.pfizerhelpfulanswers.com
RxAssist and Rx Outreach Patient Assistance Programs:
http://www.rxassist.org
Together Rx Access: 1-800-444-4106
http://www.togetherrxaccess.com/
