• November 30, 2015 at 4:14 am

    Drug Company Shamed Into Giving Treatment to a Dying 7-Year-Old

    a North Carolina drug company told the parents of a dying seven-year-old that they couldn’t sell him a potentially life-saving treatment because doing so would slow their efforts to get the drug to market.

    Seven-year-old Josh Hardy had already beat cancer three times, before he caught a virus in January that put him in heart and kidney failure, vomiting blood multiple times a day.

    His doctors said an unapproved anti-viral drug called brincidofovir could save his life. But when Josh’s parents petitioned the manufacturer, Chimerix, for a compassionate care exception, they were shot down immediately:

    When asked how he will feel if Josh dies — and he’s in critical condition, so sadly that could happen soon — the president of the company that makes the drug doesn’t hesitate to answer.

    “Horrible,” said Kenneth Moch. He would feel horrible and heartbroken.

    But still, he said there’s no way he’s going to change his mind. There’s no way he’s going to give Josh this drug.

    The FDA’s compassionate care exception “allows patients with serious or life-threatening diseases who have exhausted currently available treatment options to access experimental drugs outside of clinical trials.”

    Moch told CNN that Chimerix wouldn’t help Josh because of the high cost—approximately $50,000—and because it would “divert manpower” from the 50-odd employee company. But when a representative from the Max Cure Foundation offered to cover the cost, Moch rebuffed him, apparently citing the ethics of the situation.

    An NYU bioethicist said that companies can also be resistant to compassionate care exceptions because they can skew the drug trials:

    It’s not just the $50,000 per patient that might make investors squeamish, Caplan said, but compassionate cases can make a drug look bad. By definition, compassionate use patients are extremely sick, and might not do well with the drug. Companies have to report that poor outcome to the FDA in its application to market the drug.

    But the bad press eventually outweighed those concerns, and the company found a workaround: today Chimerix announced Josh will be the first patient in a new clinical trial that is set to start tomorrow.

    “I’m happy for Josh and I’m happy for many patients,” Moch told CNN. “We’ve come up with a way of helping not just Josh, but helping other patients in need, and there are many.”

    Courtesy – Gawker