Nov 182011

The FDA approved Avastin in 2008 even though the clinical studies did not show any benefit. There were some studies showing that the drug slowed tumour growth. The studies were obviously done by the drug company. The medical advisory panel recommended that Avastin should not be approved because it was not effective. The FDA approved it anyway. Therefore thousands of women suffered from side effects of Avastin, without getting any benefit. Their insurance companies spent $100,000 a year for each patient. The insurance companies raised premiums for everybody to cover their costs.

Several clinical studies and two more advisory committee meetings were conducted to answer the question if Avastin was safe and effective. Finally the FDA saw the light of day and withdrew its approval of Avastin for breast cancer.

Meanwhile Genentech made 6 billion dollars every year, selling a drug that does more harm than good. Welcome to miracles of modern medicine!

 Posted by at 10:29 am
Nov 072011
On November 3, 2011, the FDA issued a press release. The FDA approved 35 new medicines in the last year, the highest in last ten years. 24 of these were approved in USA before they were approved in the European Union. The FDA congratulated itself. The press bulletin also gave instances of great work by the FDA like,“Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits;.”
Is this good for the society? A government agency is doing a fast job without regard to “safety and effective” in mind. The melanoma drug that the FDA is gloating about is Peginterferone. It was analyzed under the title “Am I missing something” in this blog. Basically it does not increase the survival time. It only increases the time to relapse and during the whole time the patient is miserable from the side effects of Peginterferone. No treatment is probable better because the patient if free of side effects and is going to live a more productive life and the patient is going to live just as long as someone on Peginterferone.
Among the 35 new medicines approved are likes of roflumilast. It is another theophylline for COPD. However it is probably less effective and has potentially more serious side effects. We will never know for sure since there are no comparative studies between roflumilast and theophylline.
The FDA is doing a disservice to this nation by approving drugs for sake of approval. There is a need of regulation so that only safe and effective drugs are allowed in the marketplace. The old days of snake oil salesmen are here again. Thank you FDA.
 Posted by at 12:47 pm