Ethics in Plasma-Derived Medicine
Blood embodies life, health, and nobility—yet also signifies disease, death, and exploitation 1 .
This duality lies at the heart of plasma-derived medicinal products (PDMPs), therapies extracted from human plasma that treat over 100 life-threatening conditions, from hemophilia to immune deficiencies. Globally, 70% of source plasma comes from paid U.S. donors 3 , igniting ethical debates that pit altruism against necessity, and safety against accessibility. As demand for immunoglobulins surges by 10-15% yearly , understanding these tensions becomes urgent.
The Council of Europe's Oviedo Convention declares the human body must never be a "source of financial gain" 2 . Yet plasma—unlike organs—regenerates, blurring lines between donation and sale.
Critics argue paying donors reduces the body to a factory, violating Kant's imperative: "Never treat humanity merely as a means" 7 . Proponents counter that fair compensation (e.g., $30–50 per U.S. donation 5 ) respects autonomy, especially when plasma fuels a $24 billion industry .
Paid plasma centers cluster near poverty zones, shifting the "donation burden" to economically vulnerable groups 2 . In Germany, compensated plasma doubled supply—but 80% of donors were low-income students 3 . This raises distributive justice concerns: should the sick rely on the poor?
The 1980s tainted-blood scandals (e.g., HIV-contaminated plasma) linked paid donations to higher disease risks. Modern screening and pathogen inactivation now equalize safety between paid/unpaid plasma 3 5 . As Health Canada confirms: "No cases of HIV transmission from paid-donor plasma have occurred in 25 years" 5 .
| Acceptable | Ethically Questionable |
|---|---|
| Travel reimbursement | Cash beyond wage replacement |
| Small tokens (t-shirts) | Exploitative payments |
| Flexible scheduling | Targeting vulnerable groups |
The U.S. FDA's 1992 plasmapheresis nomogram capped donations by weight alone, allowing up to 42% of total plasma volume per draw—a risky limit for smaller donors 6 . The IMPACT trial redesigned this to personalize volumes using hematocrit, weight, and height.
| Metric | 1992 Nomogram | IMPACT Algorithm |
|---|---|---|
| Avg. Plasma per Donor | 690 mL | 745 mL |
| Donors Exceeding Safety Threshold | 12% | 3% |
| Hypotensive Events | 1.2% | 0.8% |
| Donor Profile | 1992 Volume | IMPACT Volume |
|---|---|---|
| 150 lb, 5'4" woman | 825 mL | 720 mL |
| 180 lb, 6'0" man | 825 mL | 880 mL |
| Tool | Function | Ethical Significance |
|---|---|---|
| Plasmapheresis Machines | Separate plasma from blood cells | Enable frequent donations (2x/week); require donor comfort safeguards |
| Pathogen Inactivation Systems | Kill viruses (e.g., HIV, hepatitis) | Make paid/unpaid plasma equally safe |
| Hyperimmune Plasma Protocols | Boost antibodies via donor vaccines | Raise "means vs. ends" questions 7 |
| Fractionation Facilities | Isolate proteins (e.g., albumin, IgG) | Cost $1B+; drive industry consolidation |
Immunoglobulins (Ig) exemplify PDMP fragility:
Non-profits supply plasma to manufacturers at regulated prices, blending altruism and industry 3 .
Genetically engineered factors replace plasma-derived ones (e.g., for hemophilia) but cost 3x more 3 .
Egypt's national self-sufficiency project shows emerging economies can reduce import reliance 6 .
Plasma ethics balances on a "thin red line" between life-saving innovation and human dignity 7 . The path forward requires: