A Guide To ACCESSING TREATMENTS
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Statement of purpose
Patients/consumers, physicians and caregivers sometimes find it difficult to keep up with the ever-changing treatment options for
HIV/AIDS and related opportunistic infections (OI's). The aim of this guide is to help clarify the many different avenues of access to approved and unapproved conventional and unconventional treatments for
HIV/AIDS and OI's. It can be used by both physicians and patients/consumers to help gain access to a desired treatment.
How to access treatments
The first step is always to consult your
physician. Your physician can find out for you if the treatment you want is approved for sale by the Health Protection Branch (HPB) of Health Canada for treatment of HIV/AIDS or OI's.
If the treatment you want is approved, your physician can simply prescribe it. Eg. Cimetidine, AZT
If the treatment you want is unapproved, but available, there are a number of routes by which you may access the treatment:
EDRP (Emergency Drug Release Program)
Many pharmaceutical companies allow access to treatments which are not as yet approved for sale in Canada. The
Drugs Directorate of the Health Protection Branch (HPB) of Health Canada sponsors the Emergency Drug Release
Program (EDRP). Your physician must apply to the EDRP for the drug you want. There may be a charge for the treatment.
Eg. THALIDOMIDE, CLOFAZIMINE
Open label trial
(Also called compassionate use, expanded access or parallel track.) Some Phase II and Phase III clinical trials have a
compassionate arm for people who do not fit the exclusion and inclusion criteria of the controlled clinical trial. This
means you may be able to access the treatment without actually participating in the study. However, there may be rules.
For example, you may not know what dosage you are receiving of the treatment. Approach the site investigator of the trial through your physician.
Controlled clinical trial
Providing you fit the inclusion and exclusion criteria, you could participate on a clinical trial. It is important to remember
that in a controlled trial you may receive a placebo, or the treatment in combination with another treatment. Make sure
you understand the design of the trial before giving your informed consent to participate. In order to participate on a
controlled clinical trial, you must approach the site investigator of the trial through your physician.
N of 1 trial
You may be able to access a treatment by getting your physician to apply for you to be in a "trial" of one participant only
� you. This is similar to a Treatment IND (Investigational New Drug) in the U.S. An N of 1 Trial is rare and considered more of an academic model of a trial.
Some unapproved treatments may be available through Canadian or U.S. Buyers' Clubs. These are quasi-legal agencies
which were initially set up to provide low-cost treatments to the community by buying up large quantities of the treatment
in demand. Contact your local community ASO (AIDS Service Organization) for information, contact numbers and addresses.
Eg. PEPTIDE T
Health food/vitamin stores
Many unconventional treatments are available through health food and vitamin/supplement stores. Contact your local
ASO for the names of stores which specialize in HIV/AIDS related treatments, or the names of reputable practitioners of complementary/alternative therapies.
Eg. N-ACETYL CYSTEINE (NAC)
If the treatment you want is unapproved, and available, there are a number of routes by which you may gain access to the treatment:
Wherever, whenever, and however you can, seek out information about the treatment you want to access. Contact your
local ASO, treatment activist organization (AIDS Action Now!), other persons living with HIV/AIDs (PHA's), the media,
and anyone you can think of. The more support you have, the better chance of eventually accessing the treatment you want.
Initiate a local site for a clinical trial
Start with a referral to an HIV specialist from your physician, along with a letter of support from your physician for access
to the treatment you want. If a trial is already planned or underway in other centres, the HIV specialist may try to initiate
a local site to the trial. This would also be dependent on the manufacturer's interest in expanding the trial to include new sites.
Advocate for a compassionate arm to a clinical trial
If a clinical trial of the treatment you want to access is taking place or in planning, you can approach the manufacturer to include a compassionate arm in the study.
Advocate for inclusion on the EDRP
Approach the manufacturer via your physician for the treatment to be made available through the EDRP. Both the EDRP and the manufacturer must be contacted separately once the process is initiated.
Initiate a new clinical trial
You can approach an HIV specialist to initiate a proposal for a new clinical trial of the treatment you would like to gain
access to. If the specialist can be convinced that the trial is worthwhile, it will still be a long time before a trial can begin.
The specialist must write a proposal, develop a protocol, consult physicians for participants, pass the proposal through a
hospital ethics review board, the HPB, apply for funding, etc. etc. This would also be dependent on the manufacturer's interest in pursuing a clinical trial.
There are many avenues by which you can advocate for access to the treatment you want: hospital community advisory
boards, patient relations departments, federal and provincial government offices (your local MP, MPP, Minister of Health,
etc.) The Social Work Department of the hospital may be able to help with accessing finances to pay for the treatment
you want. You can also approach your local ASO for their help in advocating on your behalf.
Clinical trial A test to see how well a new drug works in people and how safe it is.
Comparative trial A trial in which experimental drugs are tested against each other or against an approved drug or a placebo.
Compassionate or open arm
A branch of a clinical trial which allows people who do not participate in the research
study (because they do not satisfy inclusion criteria, the trial is not available in their geographic region or for whatever
reason) to have access to the drug or treatment being tested. Most compassionate arms are restricted(eg. T4 cell count below specified amount, intolerant to usual treatment etc.)
Emergency Drug Release Programme Your doctor may ask the Bureau of Human Prescription Drugs of Health and
Welfare Canada for the release on an emergency basis of an experimental drug if the drug manufacturer has authorized
its release. The programme applies to new drugs not yet marketable and drugs currently used in clinical trials.
Programmes designed to make experimental drugs available on a wide basis to people who do not
qualify for clinical trials, who live too far from a trial site, or who do not want to participate for any other reason.
The medical or social reasons why a person may or may not be allowed to enter a trial.
For example, most trials do not allow pregnant women to join, others do not allow people taking certain drugs, and others exclude people with certain illnesses.
Investigational New Drug (IND)
The name given to an experimental drug after the Drugs Directorate of Health and Welfare Canada has agreed that it can be tested in people.
A process in which the risks, benefits, and requirements of a trial are explained to people thinking of
joining the trial. Before entering the trial a participant should sign an Informed Consent Form, which should contain in
writing everything that was explained in person about the trial. The form should state: a) why the trial is being done and
what it hopes to prove, b) what will be done to you during the trial and how long the trial is, c) the risks and benefits of the
trial, d) other treatments available for your condition, and e) that you have the right to leave the trial at any time. Informed
consent exists to make sure that anyone thinking of joining a trial makes a decision based on complete information and that no one is pressured into joining.
Open arm (See Compassionate arm)
Open label A type of clinical trial in which researchers and participants know who is taking the experimental drug.
Opportunistic Infection (OI)
Certain illnesses such as Pneumocystis carinii pneumonia, (PCP) that people with AIDS can get and which can be life-threatenining. People with healthy immune systems do not usually get these illnesses,
even though most people have the organisms that cause these illnesses in their body already. Only when the immune
system is damaged can the organisms take advantage of the "opportunity" of this weakened state and cause damage.
A substance that has no effect on the body (often referred to as a "sugar pill") and that is given to one group in
a controlled trial. Placebo trials are no longer considered ethical in trials for which a standard treatment exists. Their use remains controversial.
The doctor in charge of a clinical trial.
Protocol A detailed plan which states a drug trial's rationale, purpose, drug dosages, length of treatment, how the drug
is given, who may participate (inclusion/exclusion criteria), and how those running the trial will determine if the trial was a
success or a failure. The protocol must be approved by a Research Ethics Board and the Health Protection Branch.
A trial in which people are assigned to one of two treatments by chance. Usually a computer is used
to be sure that everyone has the same chance of getting either drug. This ensures that other important or even unknown
factors which might affect how people respond to treatment are equally distributed in the control and test groups.
Research Ethics Board (REB)
Every institution or hospital that conducts research involving human subjects must, under guidelines issued by the Medical Research Council, have an REB that initially approves and periodically reviews the
research to protect the rights of the people in the trial. The REB is made up of people from various communities who are not involved in the research being done.
*The Toronto Hospital does not recommend, advocate, or endorse the use of any particular type of treatment described in
the information provided. Because of the rapidly changing nature of information about treatments and regulatory bodies
governing access to treatment, individuals should gather as much information as possible before making health
management decisions. Such decisions should always be made in consultation with a physician or other qualified health care provider.
**Glossary definitions reproduced courtesy of AIDS ACTION NOW.
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