Legal, Ethical, and Social Issues
Legal
Many patients might benefit from combination therapy but conflicts between competing pharmaceutical companies, government regulatory agencies and academic institutions often interfere with one another and prevent initiation of the novel treatments.
Legal Barriers to Combination therapies include:
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Intellectual Property - companies don’t want to share their knowledge and risk financial loss
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Contracts - one party may want to capture more value from the partnership that is warranted by its contribution
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Antitrust Law -prohibits one partner from developing combinations with products of third companies
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Product Liability - rarely a factor in clinical trials involving serious illness
Ethical
Determining the true efficacy of immunotherapy is difficult and it is an emotionally charged issue.
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There must be proven scientific benefit to the proposed therapies without posing undue risk to patients.
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Advocates for use of these therapies must be unbiased. Public interest groups and blogs by patients with personal experiences can influence and pressure consumers.
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Understanding both personal beliefs on uses of vaccines and possible potential long term risk must be weighed before proceeding with immunotherapy options.
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Clinicians and patients should be prepared for when immunotherapy doesn’t show expected results.
Social
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Psychological side effects of immune therapies: symptoms and pathomechanisms
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Possible anxiety, depression and fatigue side effects of long term interferon-alpha well known
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Immunotherapy augments a patient’s own immune system
Problems and Challenges of immunotherapy
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Paying for immunotherapy will pose significant challenges because the Centers for Medicare & Medicaid Services and private insurers are having a hard time keeping up with approved and recommended indications for various cancers.
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most adverse events, such as fatigue, headache, abdominal pain, colitis, and itchiness, can’t be identified on physical exam and the treating physician has to rely on the patient to make him/her aware of any new symptom or worsening of existing symptoms
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Patients are sometimes reluctant to report low-grade events because they want to continue treatment, and they tend to self-medicate and tell their oncologist only when the symptoms get worse
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The cost of these agents is staggering—higher than any previous class of cancer treatment.
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Large-scale development and manufacture also poses problems
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Data exchange should permit information to be shared across clinicians, laboratories, hospitals, pharmacies, and patients regardless of the application or vendor
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Misconceptions of immunotherapies and potential benefits
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Many of the misconceptions about immunotherapy’s potential are due to our limited understanding of the immune system and how it serves to protect us from disease
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