Michel Looy, Thursday 18 June 2015

Availability of Trial Drugs

This paper presents a summary, an analysis, and my opinion of a current medical ethics
issue in the United States. The article used, was published in print on May 7, 2015, on page A1
of the New York edition of the New York Times with the headline: Company Creates Panel for
Access to Trial Drugs. The writer of the article is Richard Perry.
Johnson & Johnson, the worlds fifth-largest pharmaceuticals company, has appointed
Arthur L. Caplan to create a panel that will make decisions about patients requests for
potentially life saving medicine, that have not yet been approved. A small but growing number of
patients with terminal illnesses seek the right to obtain drugs that are not yet available to be
used in healthcare. In order for a patient to receive trial drugs, both the FDA and the
manufacturer have to approve the request. Manufacturers dealing with these requests face
several issues. Making the drugs available might interfere with the clinical trials and might delay
the approval, the demand might be larger than the availability, and with the limited availability it
is hard to make a decision on which patients will and which ones will not be offered
compassionate use. A financial reason for companies to limit the availability is that trial drugs
are usually offered for free. Companies can by law only charge manufacturing and other direct
costs for these drugs. Many manufacturers will offer the drugs for free, rather than make their
profit margins public. Some patients whose requests for trial drugs have been denied, turn
towards social media to publicize their case in an attempt to change the manufacturers
decision.
Chimerix turned down Josh Hardys request for trials drugs, but then changed the
decision after the company and its executives received innumerable phone calls and social
media requests. Josh responded well to the treatment. On the other hand, Merck and BristolMyers Squibb turned down Nick Audens request for trial drugs and he died in November 2013. I
think it is very understandable that a patient that is diagnosed with a terminal illness, will do

anything to find a sparkle of hope for an effective treatment. I consider it to be appropriate for
patients to file requests for trial drugs. The companies dealing with these requests have to
decide if they will offer the patient a right to use the trial drugs. However, since the drug is not
yet approved it might not work, or might even cause harm. Thus, the health care ethical
principles of justice and nonmaleficence are involved with this issue. It is my opinion that the
company receiving this kind of a request is responsible for making an ethical consideration
based on the situation, the availability and the progress of the clinical trial. I believe that the right
and wrong in this situation is not so much found in the outcome or decision made, but much
more found in the question whether or not an ethical consideration was made. If the
consideration was made and properly communicated, a social media bomb is inappropriate.
Exaggerated attention from social media could lead to unfair and selective allocation of the trial
drugs, which is a form of medical injustice and unethical behavior. Making these considerations
and decisions can be hard, both for the company as well as for the patients and families
involved. That is why I think that Johnson & Johnson is setting a remarkable example for the
industry by forming an ethics committee that will deal with these issues and requests.