Tomahawk, WI 08/11/2014 (Basicsmedia) – Bristol-Myers Squibb Co (NYSE:BMY), Merck & Co., Inc. (NYSE:MRK) and Genentech have developed a drug for a rare form of cancer which Natalie Traller a patient suffering from a rare form of cancer had hoped could be allowed to use on Compassionate basis before final clinical testing. The drug named PD1 is an immunotherapy drug being developed by Genentech, Bristol-Myers and Merck, who have said no to Natalie on the basis that she is 15 years and could not be enrolled into the trial phase. The pharmaceutical companies have reiterated that they will only carry out trials on patients above the ages of 18 years.
“PD1 is part of a new class of experimental drugs called the immunotherapies the Trials and the Oncologists have asked Genentech and Bristol-Myers & Squibb and Merck & Co., Inc.(NYSE:MRK) for access. They have all said no. […] compassionate use is away for companies to provide experimental drugs outside of the clinical trials for patients without any other options,” said CNBC’s Meg Tirrell.
The risks involved in the use of the drug being developed by Bristol-Myers Squibb Co (NYSE:BMY), Merck and Genentech are considerably high taking into consideration the drug has not yet passed clinical stage trials. The companies might also have opted out of the trial because the drug may result in uncontrollable side effects that might reduce the chances of the drug being approved by the FDA.
“[…] I certainly have a concern about using a medication that we have no information on because its side effects can be very serious. Potentially life threating, “said Dr. Lara Davis OHSU Sarcoma Specialist.
Patients usually enrolled into compassionate drug usage are usually sick according NYU Bioethicist, Art Caplan, who chances of survival are usually minimal. Ethical considerations are also an issue in terms of who to say no or yes to according Biogen Idec Inc. (NASDAQ:BIIB) Research and Development EVP Doug Williams.
Merck Bristol-Myers and Biogen are also in a dilemma on the fact that a bad outcome on the use of the drug on a compassionate use could considerably affect their reputation especially with other probable future drugs.