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Biologic Superbowl, Remicade and Children: Canada bans, US approves

March 2, 2008

(note: Roger and Tony are fictional characters but the information they share is real)

Please welcome back Roger Seco (RS) and Tony Ventris (TV). This is their second segment on inflammatory bowel disease marketing. Not knowing what to do since the superbowl ended, they've decided to turn some of their free time toward watching the drug market for gut problems.

Roger, Tony, for this segment, you were going to tell us about a recent Lancet article.


RS: There's been a change in plan. We're going to delay our look at the Lancet to do a quick segment on the take-no-prisoners spirit of Remicade's marketing team.

TV: Once they decide to do something, they go for it. Their tactics aren't for the faint of heart. Back in 2005, they applied in the US & Candada to have Remicade approved for children.


RS: The decisions came down a year later. Let's look at what Health Canada (our neighbor's FDA) said:

> REMICADE® is not authorized in Canada for use in children.

> A rare form of cancer (hepatosplenic T-cell lymphoma), a lymphoma that affects the liver and spleen, has been reported in children and young adults taking REMICADE® for Crohn's disease.

(note: Hepatosplenic T-cell lymphoma is an extremely rare cancer, with only 150 cases reported worldwide since the disease was first recognized in the early 1990's. The cancer is aggressive and most patients die within 2 years of diagnosis.)

> A total of six (6) cases have been reported, with five cases resulting in death. Patients had been receiving REMICADE® for up to 4 years.

source: Health Canada Safety Information (pdf), July 2006

TV: So Canada banned Remicade for children because of the risk. That's a shame, a lot of lost revenue.


RS: The Remicade team was feeling hurt on that one. However, weeks before they had a big win in the US. In May 2006, the FDA approved Remicade for children.

TV: What did the FDA say about the cancer risk?


RS: When asked about potential risks, Dr. Steven Galson, director of the FDA's Center for Drug Evaluation, said:

"[The] FDA continues to actively and carefully monitor the safety experience with Remicade and similar therapies in an effort to maximize their very real benefits yet limit, to the degree possible, the potential for very serious toxicities"

source: FDA Approves Remicade For Crohn's Disease in Children, Wall Street Journal, May 19, 2006

TV: (chuckling) That takes guts, to ignore the children's safety. Galson sounds like part of the marketing team.


RS: Actually, Galson was called out by Congress in June 2007 for failing to disclose his meetings with pharmaceutical representatives. As head of the FDA, he's required to keep his appointment calendar public--in order to avoid confilict of interest.

TV: So what was on his calendar?


RS: From July 2005 to June 2007, Galson's calendar showed no meetings, not a single meeting with anyone.

source: 2 top FDA officials failed requirement to publicize meetings, USA Today, June 30, 2007.

TV: So Galson probably met with lots of pharma reps. Kudos. A man has to watch our for #1. He'll probably be able to land a good job after his government service. What's he doing now, after no appointments for two years?


RS: He was promoted to Surgeon General, a prestigious post as America's "Chief Health Educator."

TV: Nice.

So to sum up our segment: Remicade's marketing team lost in Canada--the government deemed the drug too dangerous for children. However, with the help of an FDA official who didn't do his job, the drug was approved in the US. That's a big win for Remicade.


RS: Not to sound soft, but what about the kids?

TV: Some doctors across the ocean have posted warnings, but who's listening to some doctors in Finland?

from: Severe adverse reactions to Infliximab therapy are common in young children with inflammatory bowel disease

Since 2000 we have introduced 141 Infliximab infusions to 23 children with severe inflammatory bowel disease. A total of seven severe adverse reactions occurred in 26% (6 of 23) of the children. Four reactions were acute (anaphylaxis n = 2; allergic reaction n = 2) and 3/4 of these children were younger than 10 years of age. Two children developed an abscess and one child had septicaemia and brain lesions related to progressive multifocal leucoencephalopathy. [boldface added]

source: Severe adverse reactions to Infliximab therapy are common in young children with inflammatory bowel disease, Acta Paediatrica, Volume 96, Issue 1, Page 128-130, January 2007


RS: Progressive Multifocal Leucoencephalopathy. PML. That's funny. The FDA pulled Tysabri from the market for PML. Remicade's simply off the FDA radar.

TV: Right That article came from a small country--Finland. No doctor will have time to read that, much less the FDA.

OK! Next week, well cover the Lancet article--and hand out an MVPP award - "Most Valuable Pharma Physician" award.


RS: Good night and good health!