Part 4 discusses whether seriously or terminally ill patients need the same protections as people with less serious diseases.

Legal Requirement:

There is no legal precedent indicating that seriously ill people, even those with terminal diseases, have less need for protection than people with less serious diseases. In United States v Rutherford, cancer patients argued that they had a right to Laetrile, an investigational drug that was said to be useful in treating cancer. Laetrile was never shown to be effective and was never approved by the FDA; however, the plaintiff argued that denying them access was an infringement on their Constitutional privacy rights to benefit their personal health. They also claimed that the safety and efficacy standards outlined in FD&C are not reasonably applicable to terminally ill cancer patients.

A District Court sided with the plaintiff and a Court of Appeals approved the District Court’s decision, but on certiorari the US Supreme Court reversed the decision. In the unanimous opinion Justice Thurgood Marshall wrote: “Nothing in the history of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety and effectiveness standards in § 201(p)(1) suggests that Congress intended protection only for persons suffering from curable diseases. To the contrary, in deliberations preceding the 1938 Act, Congress expressed concern that individuals with fatal illnesses, such as cancer, should be shielded from fraudulent cures…For the terminally ill, as for anyone else, a drug is unsafe if its potential for inflicting death or physical injury is not offset by the possibility of therapeutic benefit.”

False Hopes:

It is also true that terminally ill people are more at risk of manipulation because they are making decisions under duress. They are more likely to believe a treatment will be helpful because it provides them with hope, whereas if their illnesses were not life-threatening they may be more wary and skeptical of the same investigational drugs.

Just as the Declaration of Helsinki protects vulnerable populations (prisoners, children, and pregnant women), those who are desperately ill need protection, even if they don’t always perceive regulations to be protective. The expanded access program fails to protect terminally ill people in the same way that people with non-life-threatening diseases are protected because it allows them to be exposed to unknown risks that are otherwise considered unacceptable for the rest of the population.

The program also falsely raises the hopes of the terminally ill simply because by granting early access the FDA implies the drugs are acceptable for use.

Conclusion:

This leaves terminally ill patients needing the same protection as all other patients.

Part 5 questions whether all terminally ill patients should have equal access to the investigational drugs in question.

For more, contact the Kulkarni Law Firm.