Yee Ha – it is the end of the week. We are having unusual Spring weather here inside the Beltway. The week started off with the fabled cherry blossoms peaking, casting their pink haze over the area, record pollen counts gave some of us (me) sinus headaches, my herbs were prospering in the garden. Tomorrow we are expecting snow showers. Politics here in the Beltway do not change as frequently as the weather – would that they did.
But here is what you really care about from this week’s Roundup:
- Pet Food Fiasco Worsens, Senator Calls Hearings – As a pet owner, the story I want to go away instead gets worse. First, Sunshine Mills in Alabama announced an expansion of the recall with their dog biscuits, and you can see which brands were recalled if you like. Then, Senator Richard Durbin (D-IL) from my home state, announced oversight hearings to be held possibly as early as next week on the FDA investigation into the pet food situation. Then, the FDA announced a recall of pet chews because of salmonella. I have purchased three books on cooking for your dog. There are now 53 dog foods on the list and 42 cat foods. The story, disturbing in itself, raises the important question – if it can happen to our pet food, what is to stop it from happening to our own food?
- Zelnorm Pulled from Market - The agency requested Novartis to discontinue the marketing of Zelnorm (tegaserod maleate) due to a possible cardiac signal. Zelnorm is used to treat irritable bowel syndrome (IBS) and is one of two drugs for that condition. GSK‘s Lotronex, also approved for IBS, treats the diarrhea symptom while Zelnorm treated the constipation symptom. Therefore, it is actually the only drug approved for treatment of that aspect of the condition. One suspects that like Lotronex, which was withdrawn from the market and returned with a strengthened risk management program, Zelnorm might be back one day and in fact, the press release states "FDA has also indicated to Novartis the possibility of considering
limited re-introduction of Zelnorm at a later date if a population of patients
can be identified in which the benefits of the drug outweigh the risks. Any
such proposal would be the subject of a public advisory committee meeting before
an FDA decision."
- FDA Approves First Biologic to Treat Rare Clotting Disorder – The agency announced approval of Ceprotin, the first
biologic treatment for patients with a rare genetic defect that can cause a
potentially life-threatening clotting disorder. Ceprotin
is made from the plasma of healthy human blood donors. It is a concentrated
form of Protein C, a substance normally manufactured in the liver that circulates
in the plasma in very small amounts. Protein C plays an important role in
controlling blood coagulation by preventing the formation and growth of blood
clots. Ceptrotin is manufactured by Baxter Healthcare.
- Nice New Blog - This came to my attention this week and I wanted to share. The blog is called eDrugSearch and is by Cary Byrd who is the president and founder of eDrugSearch.com, an online
healthcare resource that enables consumers to quickly access safe,
affordable prescription medications through an easy-to-use search
engine. Check it out.
That’s it for this week folks. By the way, check me out on Monday when I’ll have another podcast posted – this time a 15 minute interview with Adam Feuerstein of TheStreet.com where we talk about what goes into the assessment of a pharma company stock as a new product is being developed.
Have a wonderful holiday weekend.