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May 3, 2005
Why Would Medarex Say No?

Hugh Hewitt noted the case of Amanda Twellman-Dieppa, a young woman facing a terminal cancer diagnosis after suffering since her teen years through extensive chemotherapy and radiation. She has tried everything to beat the cancer but has not been lucky enough to be successful. Her family has discovered that a New Jersey pharmaceutical company, Medarex, is developing a new drug (MDX-060) that targets lymphoma receptor CD30, which might help Amanda survive her cancer and take up her active lifestyle once again.

Medarex, however, initially refused to provide MDX-060 to Amanda, as it still is going through trials and is considered experimental. The company has made it through Phase II FDA trials, however, and the FDA would allow emergency use for the drug as long as Medarex agreed to its use. The drug was between trials, and told Amanda to wait for the next trial, which was supposedly a few weeks away from starting. Unfortunately, new trials were apparently delayed, and yet Medarex would not allow for the emergency use.

Late-breaking developments have Medarex's president taking up the issue personally, and hopefully a resolution can be reached tomorrow which will allow Amanda to try MDX-060. Drug companies dealing with oncological remedies must have overwhelming interest in their products from the desperately ill, so the bureaucratic response is understandable to a point. However, telling a dying woman that she has to wait for an unspecified trial period when even the FDA would be willing to certify it for her treatment demonstrates a lack of compassion that thankfully appears to be an isolated case at Medarex.

If you get a chance, drop Medarex an e-mail encouraging them to reach an accommodation with Amanda. It could save her life.

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Posted by Ed Morrissey at May 3, 2005 7:27 PM

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