Drug Company Denies Lifesaving Drug to 7-year-old

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Chimerix, a drug company that manufactures the still-developmental drug Brincidofovir, is denying the potentially lifesaving drug to 7-year-old Josh Hardy.  Josh has battled cancer four times since he was nine months old and it was after doctors realized that chemotherapy had ravaged the boy’s bone marrow that he needed a bone marrow transplant.  It was after the bone marrow transplant that the young cancer warrior was launched into a new fight.

The young boy has been diagnosed with adenovirus, a virus that attacks the heart and kidneys of those with compromised immune systems.  Because his immune system is repressed in order to allow the new bone marrow cells to take, the virus is raging through the boy’s system.  The drug company is refusing to allow the family to use the oral form of Brincidofovir in order to save Josh’s life, which is currently under development with plans for wide release in 2016.  The doctors treating the boy used the intravenous form of the drug, but that attacked his kidneys.  The Food and Drug Administration (FDA) allows for compassionate use of drugs that have not yet been released, but Kenneth Moch, president of Chimerix, says while he is “heartbroken” at the thought of Josh possibly dying as a result of the virus, he still refuses to release the drug to the family.

His mother, Aimee, resents that she has to take time away from her son’s bedside to mount the grassroots campaign to influence the family to release the drug.  She says all she wants is to tell her boy that everything will be all right, as any parent wants to when their children are sick, but she cannot do that simply because she has to try and put pressure on the drug company to try and save her son’s life.

Even as the drug company is denying the potentially lifesaving drug to the 7-year-old boy, the company is being flooded by tweets and emails from the family’s supporters.  The drug company insists that they cannot release the drug beyond clinical trials, though the FDA approved over 900 compassionate uses of other drugs not yet released for widespread use last year.

However, there are other considerations.  If Chimerix was to release the oral form of the drug to the doctors struggling to save the 7-year-old’s life, it could cost them up to $50,000, as insurance would not cover costs for the drug.  If the boy did not do well with the oral form of the medication, his case would have to be reported to the FDA, which means it could look bad for the Brincidofovir clinical trials.  In addition, those requesting compassionate use of any drug are usually dealing with patients who are incredibly sick; in Josh’s case, he is bleeding internally and in a lot of pain.  He vomits blood several times a day.

Chimerix, however, remains firm in its refusal to deny the potentially life saving drug to the 7-year-old and his family.  The drug company has said that their compassionate use program is almost over, and employees at the company have requested compassionate use of the drug have also been refused in the past.  Meanwhile, a 7-year-old’s life hangs in the balance, and his parents hold vigil by their boy’s bedside, relentless in their hope that the drug company might change its mind.

By Christina St-Jean

Sources:

CNN

Fox News

CBS 6

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