A Right to Experimental Drugs?

The subject of whether to legalize experimental drugs or not is one of the hottest political and ethical issues in healthcare today. Most of these drugs have not yet been approved and are still in contention; that is why they are referred to as phase I drugs. It is a rule that the development of drugs should follow three phases before they can be declared safe for human consumption. The tests that involve the use of animals is one of the requirements set by the Food and Drug Administration and is often referred to as the preclinical testing or phase 0.

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The first phase of testing of drugs in humans, Phase I, is often carried out on a small group of healthy volunteers using higher doses of the drug. It is done to determine the safety and tolerability of the patient to the drug. This simply means that at this point, the knowledge on the lethality of the drug is relatively unknown. After this phase, the investigators acquire a rough idea of the toxicity and the required doses. The subsequent phases are used to monitor the effectiveness of the drugs such as the reduction of symptoms with those showing effectiveness being tested against a larger, randomized therapies (Schuklenk & Hogan, 1996).

Carrying out tests with phase I drugs is not only dangerous but is also less likely to be of much significance to some patients. Such access may not be in the interest of the patient as an individual seeking treatment nor is it for the collective benefit of the people suffering from the disease taken as a group and not in the interest of the public. This is largely because in most cases the patients with terminal diseases are thought to be having a life-ending prognosis and therefore have nothing to lose (Schuklenk, 1998). The amount of time that is quite desirable left for the patient can be cut short by treatments that may be unsuccessful and may cause them more pain and hasten their death. These are just some of the unforeseen risks that may result from taking drugs that have not yet been fully approved for human testing. Secondly, the information about toxicity is relatively uncertain since it is only derived from computer simulation models and animal experiments which have a limited reliability. The uncertainty of the risks that are associated with phase I drugs create an obstacle when taking decisions that are informed and rational in which an off-study access is not in the interest of the terminally ill patient.

Another reason why the experimental drugs should not be allowed is because of the false hopes and therapeutic misconceptions that it gives to the patents. The patients who are in desperate need of medical attention may fall into the hype created by marketing pharmaceutical multinationals whose aim is to sell untested drugs. This may make the terminally ill patients to make less than smart autonomous choices that are based on false hopes. Such a problem can be alleviated by educating the patients so that they understand the uncertainties that come with the experimental agents.

The other problem lies in in the detrimental effects that may come along with the scientific integrity of the clinical trials that are currently on-going. A widespread access is likely to create an environment that exacerbates a confirmation bias on the side of the researchers, causing a substantial reduction in in the objectivity of clinical trials. The scientists may as a result overestimate the drugs efficacy while underestimating its toxicity. Such effects may slow down the processes employed during approval or even lead to improper use of the medical practices following their approval.

References

Schuklenk, U. & Hogan, C. (1996). Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues. Cambridge Q. Healthcare Ethics, 5(03), 400. http://dx.doi.org/10.1017/s0963180100007209Schuklenk, U. (1998). Drug Testing and Approval in Cases of People with Catastrophic Illness: Ethical Issues. Clinical Research And Regulatory Affairs, 15(3-4), 145-157. http://dx.doi.org/10.3109/10601339809109192