FAQ document on TGN 1412

TeGenero has provided a “FAQ(Frequently Asked Questions)”:http://www.tegenero.com/news/faqs_re_tgn1412/index.php on TGN 1412. Among the questions answered is how TGN 1412 is supposed to work and a little bit about why the severe reactions occurred contrary to expectations. It may not be perfectly satisfying, but it is something.

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Inflammation and cancer

“Research”:http://www.scienceblog.com/cms/studies_link_cancer_inflammatory_disease_10314.html at MIT(Massachussetts Institute of Technology) suggests a relationship between cancer and inflammation (including autoimmune diseases such as rheumatoid arthritis). This is one more piece in this confusing puzzle.

What does TGN 1412 mean to clinical trials?

Black Triangle “reports”:http://www.blacktriangle.org/blog/?p=1318.

How did I miss this: more warning signs for TGN 1412

This time, Tegeneron has admitted to seeing “side effects in monkeys”:http://www.medindia.net/news/view_news_main.asp?x=8679.

bq. In a pre-clinical trial that involved animals, two monkeys have been reported to develop lymph node inflammation following injection of the experimental drug. The company in response to the above issue has however said that symptoms experienced by the man had no correlation with that documented in monkeys.

I find this an intriguing statement, given that the adverse drug reaction was essentially a super-charged inflammation. It gets better:

bq. The drug company had previously claimed that there had been no drug-related adverse effects. Furthermore, the study participants were told that there had been no instances of adverse effects in the prior tests. The side effect of the drug as seen in monkeys had been high enough to warrant monitoring of the immune system and function in human volunteers.

Say what?

It’s official: Walmart tries to paint itself green

I’ve been noting for a while that MalwartWalmart has been selling organic goods. “It’s official”:http://www.msnbc.msn.com/id/11977666/.

h/t “Federal Review”:http://www.federalreview.com.

Another adverse reaction to TGN1412: madness

If “this guy”:http://pipeline.corante.com/archives/2006/03/26/a_word_to_the_wise_about_tgn1412.php is able to get an ethics board or Institutional Review Board to let TGN1412 within a thousand miles of another human being’s bloodstream, then he’s going to be able to make a lot of money without having to sell one drop of the stuff. He’d be able to sell steak to vegans.

I have a question for Dr. Hunig: which do you care about? Caring for sick people or giving sick people your drug? I don’t think organ damage will help cancer patients.

I’ve seen sanguine investigators. But nothing this extreme. I’ll follow up on Derek Lowe’s comment: this drug, is an ex-drug. (Somehow, saying “this biologic, is an ex-biologic” doesn’t have the same ring to it.)

(Side note: on the other hand, “thalidomide”:http://en.wikipedia.org/wiki/Thalidomide, the infamous teratogenic morning sickness drug that was the reason the FDA tightened regulations in the 1960’s, is on the market for leprosy and multiple myeloma. It turns out to be a useful drug if you aren’t pregnant.)

A more common occurrence in this household

Background: my three-year-old daughter is learninghas learned how to use the computer. We have her on a couple of educational websites that teach reading.

Me (to daughter on the computer): Oh, you have do this. Here are the steps: [I start describing the steps]
Daugher continues at the computer.
Me: Oh, you already know how to do that.