FDA:Approves Drugs For Our Benefit or Their$?

(NEWSER) – The FDA’s commissioner has been touting the agency’s speedy approval of new medicines—but it has brought risky drugs to market, according to two drug-safety experts. Specifically, Thomas J. Moore and Curt D. Furberg found problems with cancer drug Caprelsa, multiple sclerosis drug Gilenya, and stroke prevention drug Pradaxa, the Wall Street Journal reports. “These examples raise the question of whether it was good policy to approve three innovative new drugs with significant safety questions unanswered,” they write in the Journal of the American Medical Association.

Caprelsa is “sufficiently toxic that overall survival [was] not different from that achieved with placebo,” the authors write. Gilenya has “seven major safety issues,” including negative effects on heart rate. And Pradaxa, an anticoagulant, has been linked to dangerous bleeding. An FDA director points out that the public wants expedited drug approval:

 

Bristol-Myers Warning Ignored on Steroid Shots Tied to Deaths  Jan 25, 2012

Doctors are still injecting a steroid made by Bristol-Myers Squibb Co. (BMY) in a way the company warns they shouldn’t, following reports that patients have died or become paralyzed after receiving steroidal shots.

Bristol-Myers changed the label on its steroid Kenalog seven months ago to say that it’s “not recommended” for injection into the epidural space near the spine because of “reports of serious medical events, including death,” associated with administering steroids in that fashion. The label doesn’t specify if Kenalog patients died and a spokesman for the company declined to comment.

Used for neck and back pain, Kenalog and the Pfizer Inc. (PFE) drug Depo-Medrol are the most frequently administered steroids in epidural injections. Over eight million such shots were given in the U.S. in 2010.

 

 Oct. 04, 2012

NEW YORK – The government is warning doctors and hospitals not to use any product from the specialty pharmacy that made the steroid suspected in a meningitis outbreak.

An official with the Food and Drug Administration said tests found contamination in a sealed vial of the steroid at the New England Compounding Center in Massachusetts. Tests are under way to determine if it is the same fungus blamed in the outbreak.

Federal officials on Thursday also updated the number of cases in the outbreak. Five people have died and 30 people in six states are ill. All received steroid shots for back pain.

 The steroid was sent to 75 facilities in 23 states.

FDA Approves Drug Therapy Created from GM Plants

Genetically modified foods are dangerous to human health. Consumption of them leads to acute organ failure. Currently, countries and communities are fighting against GM food; demanding that they be labeled in grocery stores and that their production be halted in certain countries because of their devastating effects on the human population and the environment.

The Food and Drug Administration (FDA) has now approved a pharmaceutical drug that was derived from a genetically engineered planet cell.

This marks the continued relationship between genetic engineers and Big Pharma. And the profit margins could turn out to be quite substantial for both.

Elelyso is a treatment for Gaucher disease. This condition arises from a lack of the enzyme glucocerebrosidase. It affects the liver, spleen, lungs, bone marrow and brain.

Israeli engineers at the Protalix Biotherapeutics have successfully grown this enzyme in a laboratory from carrot cells. They found that the human enzyme encoded the proteins into the engineered cells. Clinical trials were promising.

 

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