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.

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.

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.

The major defense contractor KBR Inc is being sued by 16 Indiana National Guard soldiers. The suit claims its employees knowingly allowed the soldiers to be exposed to a toxic chemical in Iraq five years ago.

The suit alleges the soldiers from a Tell City-based unit were exposed to a sodium dichromate, a known carcinogen, while protecting an Iraqi water pumping plant shortly after the U.S. invasion in 2003. The suit also claims that the Houston-based KBR knew at least as early as May 2003 that the plant was contaminated, but concealed the danger from civilian workers and 139 soldiers.

The chemical, used to remove pipe corrosion, is especially dangerous because it contains hexavalent chromium, which is known to cause birth defects and cancer, particularly lung cancer, the lawsuit said. The cancer can take years to develops. Some of the soldiers who served at the site now have respiratory system tumors associated with hexavalent chromium exposure.

When Guard members and American civilians working at the plant began to have nosebleeds, KBR managers told them they were simply caused by the dry desert air, the lawsuit says.

The work was not shut down until September 2003 after KBR managers in full environmental protective gear inspected the plant while workers and Guard members remained unprotected.

One of the most important jobs of the FDA is to provide the public with clear information about drug safety. Another mission is to reveal what it knows about potentially defective drugs.

How well the FDA is doing with its primary mission is being questioned by Representative Joe Barton (R-Texas) who wrote a letter to the US Government Accountability Office: asking is the FDA telling us everything it knows?

The GAO is being asked to review the FDA’s handling of the contaminated heparin problems of 2007 and 2008. In his letter, Barton notes that the FDA’s statements to the media in July 2008 indicate that the agency had “conclusively linked” deaths of three patients to oversulfated chondroitin sulfate found in specific lots of the drug, which is manufactured by Baxter Healthcare.

Yet when Barton requested information, the agency told him in October 2008 that it was merely “possible” that heparin caused two of the deaths and that it could not assess whether heparin caused the third death, while Baxter’s investigation of the situation concluded that it was unlikely that heparin had caused any of the three deaths.

The FDA did not interview Baxter to get more information about the deaths and that inconsistency troubles Barton.

Could drug companies be cooking the books where it comes to getting FDA approval for new drugs?

Recent research published in the journal Public Library of Science Medicine shows that many drug studies submitted to and read by the U.S. Food and Drug Administration go unpublished.

In addition to that, some that are published sport inconsistencies between the study that was submitted and the study that was subsequently released. Changes included additions and/or deletions, statistical alterations of outcomes and changes in trial conclusions.

In general, reports that show the studied drug in a favorable light are much more likely to be published. Of forty-three trials that showed no benefit to the test drug, only half were published.

This kind of dishonesty in the medical field can be very dangerous, possibly misleading doctors and patients alike while they make important decisions about the patient’s health. Unfortunately, discrepancies such as these can be very hard to detect or prosecute.

The Texas defective drug attorneys at Cappolino, Dodd & Krebs are concerned about your health. Have you been injured by a defective drug? Contact us today.

The US Food and Drug Administration (FDA) is trying to determine if television drug advertisements should be required to include a toll-free number that consumers can use to report side effects associated with their medications.

While this seems to be a good idea, opponents believe that the information could “distract” consumers away from important drug safety information.  Print ads currently contain the toll-free number, and the FDA is now required by law to include the number on their TV ads. However, the FDA has had an extension in testing the effects of the number and is expected to being a study shortly. They plan on showing fictitious ads to consumer groups and then interview those groups to determine comprehension levels.

Critics of the current advertising practices claim that situations in which medications are over-prescribed before full effects are known occur too frequently. They contend that educating consumers on how to report side effects to the FDA will lead to quicker action in addressing safety problems. Right now, consumers generally tell their prescribing physician of a drug side effects, and that information is not always reported to the FDA.

The dangerous chemical melamine that has recently been found in several goods originating from China has also been found in an infant formula made by an American manufacturer.

The discovery was found in late November, and involves a single sample of infant formula that was found to contain trace amounts of the dangerous chemical.

The US Food and Drug Administration (FDA) quickly pointed out that the amounts of the chemical were too low to be considered a heath threat, but it should be noted that the increased testing for melamine is a result of a rise in tainted products from around the globe.

Earlier this year, thousands of pets had been sickened or killed by the presence of melamine in pet food, and the source of this melamine was linked to imported wheat gluten from China. Also this year, China has had serious children’s toys, tainted toothpaste, heparin, pet food, and milk recalls. 50,000 infants became ill from the tainted milk, and 4 died.