Heartbreak of Psoriasis: Enbrel and Heart Studies

by Ed Silverman | Pharmalot
March 10, 2008

enbrel2.jpgThe ongoing battle between the biotech and some former sales reps – who allege they were forced to promote the psoriasis treatment off-label and violate patient privacy – now centers on a pair of older studies showing the biologic was linked to congestive heart failure.

The issue, which is mentioned in a complaint filed by a former rep is whether Amgen disregarded study data, altered the drug warning so that only people with advanced CHF were described as at risk, and then encouraged reps to promote Enbrel as safe for anyone with congestive heart failure. The rep is suing Amgen for $10 million for wrongful termination and her complaint contains various allegations that reps were told to promote off-label and encourage docs to prescribe Enbrel to patients who may not have needed the drug.

 

The attorney representing two former reps says Amgen has declined to make the studies available, citing confidentiality. “These studies show Amgen should not have been marketing to patients with CHF or cardiovascular problems, yet this is what they were directing my client to do, regardless of whether or not they had CHF,” says Lydia Cotz, whose other client charges that Enbrel reps were told to pull patient files from doctors’ offices, orchestrate letter-writing campaigns to patients and insurers, and arrange and attend patient outreach seminars.

UPDATE: Two days later, Amgen responds. Keep reading to see what the biotech has to say.

Cotz notes that a PowerPoint presentation is available on the FDA web site, which you can look at here, since it was part of an FDA advisory committee five years ago. The slides, however, only disclose bottom-line findings. An Amgen spokeswoman writes us that the info about CHF has appeared in the Enbrel labeling “for some time,” (see pages 21 and 29 of the labeling) and that Amgen does not encourage its sales representatives to advise doctors to write prescriptions for inappropriate or contraindicated patients.”

The attorney, however, argues that the studies “may have more information than the package insert and doctors should have access to information about these studies beyond what’s in the package insert.” The Amgen spokeswoman has indicated she will attempt to respond to the confidentiality issue and, if there is a reply, we will update you. The cases, you may recall, have attracted the interest of the Senate Finance Committee, the New Jersey attorney general and the Florida attorney general.

UPDATE: The day we posted this item, we asked Amgen for a response about the confidentiality issue. Two days later, an Amgen spokeswoman writes us to say this: “The results of the studies that Ms. Cotz is seeking are publicly available information through multiple sources. As shown by the slide deck in your article, these studies (RENAISSANCE and RECOVER) were reviewed and analyzed by the FDA five years ago and the slides are still available on the agency’s web site. A meta-analysis of the data from these studies (RENEWAL) was also published in the medical journal Circulation in 2004, and an abstract of this journal article is available on PubMed (look here).