Archive for January, 2007
Folate Supplementation Risks Begin to Surface
As reported last September, food fortification with folate does pose some risks. Indeed I don't support fortification programs generally and I consider the folate programs to be a very bad idea. Why is this?
Essentially, folate food fortification involves the enrichment of denatured, highly refined, frequently poor quality and high risk (triggering allergies and sensitivities) grains. These flours are dangerous enough and should be completely avoided. This is an extremely unpopular position to take because grains marketing through Departments of Agriculture and 'scientific' associations has assumed a health-righteousness that supports an erroneous orthodox view that grains are essential sources of nutrient needs. Unpopular to be sure, but a position I stand by nevertheless.
Aranesp (darbepoetin alfa) by Amgen Found Ineffective and Dangerous
Many patients being treated for various cancers develop anemia. Aranesp is approved by the FDA for the treatment of patients with anemia, which is caused by chemotherapy treatment of their malignant disease, rather than the underlying malignant disease itself. Essentially, it is a toxic drug which attempts to overcome some of the damage caused by other far more toxic drugs.
Amgen, the maker of Aranesp, conducted a large, multicenter, randomized, placebo-controlled study that showed Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp.
FDA Safety Information and Adverse Event Reporting Program Updated 26 Drug Products’ Details in November 2006
Safety-related drug labeling changes for November 2006 have just been posted on the MedWatch website. There is always quite a delay between making and notifying about the changes. There are probably some plausible reasons for this delay if you are sympathetic to bureaucratic thinking but I find it rather excessive.
The November 2006 posting includes 26 drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.
The Summary page provides drug names and a listing of the sections changed and may be accessed via the following link.
FDA Upset at Misreporting on Newer Birth Control Pill
It seems that the US Food and Drug Abomination, oh sorry, Administration (FDA) has become upset by what it regards as misreporting by the wire services. No doubt the FDA would be made feel uncomfortable by its pill-pushing friends if it didn't clear this up. So we are treated to a fairly rare event: the FDA is clarifying the interpretation given to its actions.
The FDA released the following statement. It speaks for itself.
FDA Statement on Effectiveness of Newer Birth Control Pills
Recent wire service stories about today's meeting of the FDA Reproductive Health Drugs Advisory Committee have created misperceptions about the effectiveness of newer generation hormonal contraceptives.