Question

What are 2 pros and 2 cons from regulation of clinical research, why it should be regulated?

Answer 1

Cons

1.Safety Consequences: Nearly 70% of drugs pass phase I testing. However, most drugs that pass phase I will be deemed unsafe or ineffective, failing to pass subsequent stages. There is a low probability that experimental drugs tested in early-stage research will significantly benefit patients and a higher probability that side effects from experimental interventions could worsen their condition. Additionally, the FDA expanded access process has been revised to be more transparent and to take less time: patients can now complete the expanded access request form within an hour. Right-To-Try legislation has helped make undertested drugs more readily accessible by reducing FDA oversight, which was created to protect patients and consumers from unsafe pharmaceuticals

2. Decreased Liability: One of the most problematic issues with the federal Right-To-Try legislation is provided immunity from liability for physicians and pharmaceutical companies (2,4). Without FDA oversight, pharmaceutical companies can push unsafe drugs on sick patients. Although it is presumed that primary care physicians have their patient's best interests in mind, physicians can own pharmaceutical company stock and charge patient treatment fees (2). Pharmaceutical companies, for their part, need to have no fear that any negative outcomes from experimental drugs will hurt the chances of the drug becoming FDA approved, as this legislation prohibits the FDA from including negative outcomes of experimental treatments in the data that are used to approve the pharmaceuticals.

Pros

1.Experimental Drugs May Extend Life: In most cases, experimental treatments have not yet proven effective. However, they can potentially extend life. Compassionate use has been used in epidemics with a high death rate. Widely untested therapeutic vaccines were given to people living with Ebola in hopes of improving their condition. Given a setting of compassionate use, even unsuccessful treatment may help strengthen patients’ trust in health-care systems due to potentially positive health outcomes.

2.In-Line with Expanded Access: The case for the terminally is to potential life-extending drugs. The Right-To-Try legislation is very similar to the Expanded Access program in that it recognizes that a streamlined process is necessary if experimental drugs are to reach patients who may not have any other options.

One of the main principles the Right-To-Try law was built on ways to reduce pain and suffering. However, bypassing FDA regulations means the data that would normally be available for physicians and clinical researchers, such as dosage, drug administration, and side effects, will be limited. The potential for lowered trust in the clinical research enterprise, financial and safety consequences, decreased liability, and limited patient understanding clearly outweigh the potential benefits of the experimental drugs.