Archive for December, 2008

Who will take over leadership of the FDA?

Sunday, December 28th, 2008

As President-Elect Barack Obama’s administration comes together, one very important spot is the choice of  commissioner of the US Food and Drug Administration.

The next commissioner will need to be prepared for the policy and operational issues currently occurring at the FDA. Over the past few years, the FDA has received much criticism about its ability to enact drug-product safety (such as in the case of defective drugs like Vioxx) or adequately regulate manufacturers and the inspection of their facilities (in the contaminated heparin case).

Several names under consideration are Joshua Sharfstein, the commissioner of health for the city of Baltimore; Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic; and Janet Woodcock, the current director of the Center for Drug Evaluation and Research at the FDA, among others.

CDC determines tainted Baxter heparin culprit

Tuesday, December 23rd, 2008

The Center for Disease Control has confirmed a counterfeit ingredient was in the tainted heparin that caused many allergic reactions and deaths last year.

According to the CDC, drug manufacturer Baxter Healthcare is “the factor most strongly associated with reactions.” In January of this year, Baxter International recalled almost all of its heparin injections in the US after some patients experienced extreme allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening.

The FDA identified 93 deaths and hundreds of cases of allergic reactions associated with the defective drug between January 1, 2008 and March 31, 2008.

According to the CDC study, the agency has identified 152 adverse reactions associated with heparin in 113 patients from November 19, 2007 through January 31, 2008. The CDC said that Baxter heparin was present in 100 percent of case facilities versus 4.3 percent of control facilities.

“Of 130 reactions for which information on the heparin lot was available, 128 (98.5 percent) occurred in a facility that had OSCS-contaminated heparin on the premises. Of 54 reactions for which the lot number of administered heparin was known, 52 (96.3 percent) occurred after the administration of OSCS-contaminated heparin,” the study said.

Defective drugs can cause harm and, sadly, fatalities. If a defective drug has harm you or a loved one, contact an experienced defective drugs attorney for professional insight.

Beware stem cell scams!

Tuesday, December 23rd, 2008

Watch out for illegitimate stem cell therapies being sold over the Internet. Canadian researchers recently looked at about 20 websites found through a simple Google search that claimed to sell stem cell therapies.

Though researchers are continuing to make leaps in new applications for stem cells, the expensive stem cell therapies marketed over the Internet for everything from strokes to allergies are scams.

There are two distinct kinds of stem cells. The first, embryonic stem cells, are the most controversial and are strictly regulated in the United States. The second, adult progenitor stem cells, are taken from the patient themselves. It is unclear from the websites what kind of stem cells they were attempting to market, whether or not they were actually real, or where they had come from.

Though there has yet to be any report of someone being injured by one of these scams, patients should steer clear. For your own safety, do not attempt to undertake serious therapy of any kind without consulting your doctor.

If you have been injured by a defective product, call the Texas trial attorneys at the law office of Cappolino, Dodd & Krebs today.