Fight Colorectal Cancer

XELOX, as second-line therapy, was found to be as effective as the more commonly used FOLFOX treatment for patients whose cancer had already gotten worse on treatment with Camptosar® (irinotecan).

XELOX combines an oral drug Xeloda® (capecitabine) with Eloxatin® (oxaliplatin).  FOLFOX uses an infusional schedule of 5FU and leucovorin.

Researchers randomly compared XELOX to FOLFOX4 to treat 627 patients with metastatic colorectal cancer.  Patients had already received initial therapy with Camptosar and either had their cancer progress or were unable to tolerate the treatments.  Although outcomes were similar for the two regimens, side effects differed.

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As I reported yesterday, the Bush administration amended the FY 09 budget to include an extra $275 million for the Food and Drug (FDA) Administration. A valid attempt to make the situation right, it seems it may be too little too late.

In a letter from Senator Arlen Specter (R-PA) to Secretary Michael Leavitt (Health and Human Services), Specter said the FDA’s request on Monday for an additional $275 million wouldn’t give them any money until March or April 2009 “at the earliest.”

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The FDA has announced a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets by Ethex Corporation. Lot No. 91762, distributed between April 16th and April 27th of 2008, contained at least one over-sized tablet that might contain up to twice the amount of morphine.

While no reports of serious effects from Ethex morphine tablets have been reported, the opioid medicines are being recalled to prevent life-threatening overdoses.

Extended release morphine is often used to manage cancer pain, particularly in patients with advanced disease.  Since many of these patients are already weak, it might be difficult for them to recognize an over-sized pill.

Signs of morphine overdose include difficulty breathing and low blood pressure. If you suspect an overdose contact your doctor immediately or call 911.

Patients or caregivers with questions about the recall should

• Contact their doctor or pharmacist
• Call ETHEX Customer Service at 1-800-321-1705
• Email customer-service@ethex.com

Ethex representatives are available Monday through Friday, 8 am to 5 pm CST.

We are very pleased to announce that the Administration has taken the highly unusual step of amending its FY 2009 budget to include an additional $275 million for the FDA.

Last month we let you know the Food and Drug Administration (FDA) Chief, Andrew Von Eschenbach, wrote a letter to Senator Arlen Specter (R-PA) expressing the dire need of an influx of $275 million. This was very unusual for a political appointee to go against the proposed budget of the President.

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Update from 2008 ASCO Meeting in Chicago

Provigil® (modafinil) reduced fatigue in cancer patients receiving chemotherapy according to a study reported by Gary Morrow PhD at the 2008 ASCO meeting.

Patients who were severely fatigued after their first chemotherapy treatment had less fatigue after they received Provigil than those who got a placebo. They were also less sleepy during the day.

Severe fatigue was considered more than 6 on a 10 point scale. Patients with mild or moderate fatigue did not have a similar improvement.

Despite improvement in severe fatigue, there was no effect on depression. Read the rest of this entry »