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Amgen Accused of Falsifying Medical Records, Lying to Patient in Enbrel Trial

By Jim Edwards | May 29, 2009

A Los Angeles man has sued Amgen claiming that the company lied to him in order to enrol him in a trial for Enbrel, and that he lost all his body hair as a result. William Moke, 40, claims that when he discovered his condition should not have been treated with Enbrel his doctor and Amgen destroyed some of his medical records. (Download a copy of Moke v. Amgen here.)

In 2004, Moke went to his doctor, Vernon Wilson, with a case of “slight” psoriasis. Even though the indication for Enbrel is moderate-to-severe psoriasis, he was encouraged to enrol in an Enbrel trial by his doctor and representatives of Amgen. He was provided the drug free. Moke claims that Amgen found him because they got hold of his medical records “without plaintiff’s knowledge or consent.”

Amgen and Wilson then allegedly altered his medical records to make his condition appear more severe than it was  — thus fitting the indication for Enbrel — without Moke’s knowledge.

Moke claims he was not advised that a side effect of Enbrel is loss of body hair. In fact, Moke alleges, he complained to his doctor that he wanted to avoid a competitor’s drug because hair loss was a side effect. In 2005, after months on Enbrel, “all of plaintiff’s hair fell out completely, except for small amounts on his eyebrows. Plaintiff is currently without any hair on his body. He has no body hair, nose hair, eyebrows or eyelashes,” the suit states.

The Mayo Clinic advised Moke to stop taking Enbrel. At this point, Moke asked for copies of his medical records. The suit alleges:

Dr. Wilson repeatedly refused to provide those records, stating that defendants did not permit him to disclose them.

He eventually obtained some of his records, and alleges the rest were destroyed. The suit claims that Amgen’s marketing of Enbrel is “untrue or misleading” because it downplays the risk of hair loss.

Amgen has yet to file a response.

Jim Edwards, a former managing editor of Adweek, has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University's business and journalism schools. Follow him on Twitter or send him an email.

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