An article in the January 2011 issue of “Vanity Fair” details the globalization of our nation’s pharmaceutical trials.

As recently as 1990, the vast majority of drug trials were conducted in the U.S. or Europe. Today, pharmaceutical companies conduct most of their human testing in India, Africa and China.

It’s a lot cheaper and there are fewer regulations these companies much follow — in fact, in many of these countries, nothing regulates drug experiments on humans.

Further, there is absolutely nothing that demands transparency for these trials which lets drug makers pick and choose which trials they use to apply to the U.S. Food and Drug Administration for permission to market drugs in this country.

The FDA depends heavily on these trials. Because our enforcement mechanisms are so dangerously thing — as demonstrated in the heparin scandal — the FDA has precious little ability to oversee drug trials in this country, much less the more than 6,485 trials conducted overseas (in 2008).

Many of the drugs that are currently facing harsh criticism are the very drugs that relied heavily on these overseas trials. Studies for drugs like Celebrex, Ketek, Seroquel, Avandia and Paxil were conducted overseas, and the results of those trials — usually only the trials that showed the drug in the most positive light — used to gain FDA approval.

Often, these drug companies test drugs on children, even when their own researchers insist that the drug will have a limited benefit. Western countries have rigid regulations about testing on children but these regulations do not exists in most third world countries. Parents of these children — who are often illiterate and quite poor — are paid $350 per child enrolled in these studies but seldom told that they were taking part in an experiment.

The article makes the point that drug makers really do put profit first, and have only passing regard for the lives affected by the dangerous and defective drugs they make.

The article cites on study which revealed that, in 2009, 19,551 people died as a direct result of the prescription drugs they took, and that is just the reported number; only about 10 percent of such deaths are reported.

This puts the number of deaths due to FDA-approved drugs near 200,000 — dwarfing the number of people who die every year in car wrecks.

If you or someone you love has been harmed from using a dangerous or defective drug, please contact an experienced defective drug attorney for professional insight.

Once again, the blood-thinning drug heparin has been linked to fatalities in patients. Five patients at Beebe Medical Center in Delaware fell ill after being treated with heparin IV bags. Two of the patients have died.

The IV bags contained diluted heparin that has been approved for a number of blood-thinning purposes. All five bags came from the pharmaceutical company Baxter International. This is not the first time that Baxter has been linked to heparin fatalities. In 2008, they had to recall thousands of cheap, tainted heparin products.

These two recent deaths have prompted the Food and Drug Administration to launch an investigation into the incident. So far, the FDA has not accused Baxter of distributing tainted heparin, nor have they implied that heparin itself may be less safe than previously thought. They said that it was only  “unusual” circumstances in the Delaware deaths that made them decide to investigate.

An independent lab is currently testing the Baxter heparin used at Beebe.

The Food and Drug Administration has announced that the deaths of two patients treated with possibly contaminated heparin may have been an isolated incident.

Five patients recently fell ill in a Delaware medical center after being treated with heparin IV bags supplied by Baxter International. Two of the patients, a 71-year-old man and a 64-year-old woman, have died, and a third patient remains hospitalized. These three people all suffered cerebral hemorrhages.

However, the FDA has found no evidence of contamination, nor have they received additional reports of fatalities or other serious injuries linked to heparin use. The FDA has determined that this incident alone is not enough to make any decisions about the production of heparin. FDA representatives have issued statements that patients should not worry about being treated with heparin.

Anyone who has suffered a defective drug injury should contact an experienced lawyer immediately as they may be eligible to receive compensation through a defective drug lawsuit.

Heparin is a drug given to patients to help prevent blood clots from becoming big and causing serious problems.  But now it is being investigated if heparin is the cause of sickening five patients at the Beebe Medical Center in Delaware.

Wallace Hudson, vice president for corporate affairs at the Lewes Hospital, said that two of the sick patients have recovered, and no further cases have been discovered.  It is not certain when samples that have been sent to be tested will come back he said.  “We hope it’s soon.  We don’t want this thing dragging on,” he stated.  “But we need to find out what went wrong and make sure it doesn’t happen again,” he concluded.

The three other patients have been transferred to the University of Maryland Medical Center and the Christiana Hospital.

Baxter Healthcare Corporation is the manufacturer of the heparin.  They recalled batches of the drug in 2008 when the Food and Drug Administration (FDA) found that it was contaminated.

The use of heparin has been suspended at Beebe.  Representatives from Baxter were said to be at Beebe to assist with an examination of the accident.

The ability of heparin to repress clotting and coagulation makes it suspect for serious side effects if given in too large doses.  In itself, heparin is not a defective drug but some shipments of the drug, which were made in China, were tainted.

Three of the sickened patients had internal bleeding according to Hudson.  Beebe has notified the FDA along with the Delaware Health Care Operations Center.

An article published this week on the Natural News website reports that the number  of deaths and serious injuries as the result of prescription drugs more than doubled from the first quarter of 2007 to the first quarter of 2008.

According to a report  by the Institute of Safe Medication Practices, researchers found mention of 4,825 fatalities and more than 21,000 serious injuries between January and March, 2008.

The vast majority of the reported fatalities and injuries were attributed to misuse of over the counter pain medications like ibuprofen but 10 drugs accounted for  more than 100 fatalities each, more than 20 percent of the total.

The two single most lethal drugs were the anti-smoking drug varenicline — marketed as Chantix — and the blood thinner heparin. While heparin was responsible for killing a 102 people and injuring 779, the vast majority of these cases were associated with a batch of contaminated medication imported from China. Since the discovery of the tainted drugs, injuries and deaths from heparin have dropped off.

Chantix, in contrast, continues to cause high rates of injury and deaths, accounting for 50 fatalities and 1,001 serious injuries in the first quarter of the year. Since its approval in 2006, the drug has been implicated in 112 fatalities and 3,325 serious injuries. Many of these injuries were self-inflicted and stemmed from the drug’s psychiatric side effects, while others stemmed from seizures, blackouts, loss of consciousness and sudden heart arrhythmia.

If you or a loved one has suffered harm after taking a prescription drug, it is important that you seek the  professional advice of a defective drug attorney.

A North Carolina syringe factory that has been linked to the heparin scandal operated for almost two years without an inspection by the FDA. In a story published by the Associated Press the FDA failed to inspect the company even after complaints were filed about the syringes being dirty or filled with colored particles.

In 2007, before the heparin outbreak, the FDA received more than a dozen reports of problems with the AM2PAT’s syringes. Some reported “orange specks” floating inside the unopened syringes, and others reported “yellow sediment” or “muddy brown” syringes with floating white specks.

The FDA says they first received complaints of particles in the heparin syringes in November 2005. An FDA spokeswoman said the company was inspected in January 2006, but wasn’t checked again until December 2007—22 months later.

While the FDA declined to release its inspection reports from the January 2006 and December 2007 visits to the syringe plant, the reports could be released through a Freedom of Information act request.

Baxter International Inc. has assumed responsibility in the nation-wide heparin contamination that endangered the health of thousands. Though they have admitted fault for their role in the distribution of the defective drug, Baxter denies any part in “deliberate” contamination.

Reports of serious allergic reactions and deaths associated with heparin doses began late in December of 2007. By January, there were sufficient reports of adverse reactions to prompt Baxter to recall about 10 percent of their annual production of heparin.

The contamination was finally linked to heparin manufacturing plants in China last March. Since then, there have been numerous investigations to find the responsible parties, since Chinese drug manufacturing is significantly less regulated than that in the United States.

The defective drug lawyers at Cappolino Dodd  Krebs LLP take on cases of defective drugs and injury caused by negligent companies. Have you been injured due to faulty pharmaceuticals? call our Texas office today.

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.

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.