“Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas…in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach…?”

A fascinating article recently discussed the increasingly common practice of  performing clinical drug trials outside of the United States for drugs planned to be sold to U.S. citizens.  The article also talks of the minimal role of the Food and Drug Administration (F.D.A.) in regard to how it relies almost 100% on studies and data provided by the pharmaceutical company that hopes for F.D.A. approval.  There is no question that there is an inherent and unavoidable bias in how this information is presented to administration, particularly when billions of dollars are at stake.  Click here to read the entire Deadly Medicine article.

“In 2008 alone, according to the inspector general’s report, 80 percent of the applications submitted to the F.D.A. for new drugs contained data from foreign clinical trials. Increasingly, companies are doing 100 percent of their testing offshore…

Some medical researchers question whether the results of clinical trials conducted in certain other countries are relevant to Americans in the first place. They point out that people in impoverished parts of the world, for a variety of reasons, may metabolize drugs differently from the way Americans do...

One big factor in the shift of clinical trials to foreign countries is a loophole in F.D.A. regulations: if studies in the United States suggest that a drug has no benefit, trials from abroad can often be used in their stead to secure F.D.A. approval.“

Foreign studies have also been used to test on children, sometimes with devastating outcomes:

“In New Delhi, 49 babies died at the All India Institute of Medical Sciences while taking part in clinical trials over a 30-month period…The editor of an Indian medical journal said it was obvious that the trials were intended to extend patent life in Western countries ‘with no consequence or benefit for India, using Indian children as guinea pigs.’ In all, 4,142 children were enrolled in the studies, two-thirds of them less than one year old.”

The  (FDA) does little to regulate drug trials, and relies upon the pharmaceutical companies for almost all data:

“The F.D.A. gets its information on foreign trials almost entirely from the companies themselves. It conducts little or no independent research….

In 2008 the F.D.A. inspected just 1.9 percent of trial sites inside the United States to ensure that they were complying with basic standards. Outside the country, it inspected even fewer trial sites—seven-tenths of 1 percent. In 2008, the F.D.A. visited only 45 of the 6,485 locations where foreign drug trials were being conducted.”

Diabetes drug Avandia was heavily tested outside the United States:

It may be just a coincidence, but as controversy swirls around new drugs, and as the F.D.A. continues to slap medicines with new warning labels—especially the black-box warnings that indicate the most serious potential reactions—most of the problematic drugs have all undergone testing outside the United States. Clinical-trial representatives working for GlaxoSmithKline went to Iaşi, Romania, to test Avandia, a diabetes drug, on the local population. Glaxo representatives also showed up in other cities in Romania—Bucureşti, Cluj-Napoca, Craiova, and Timişoara—as well as multiple cities in Latvia, Ukraine, Slovakia, the Russian Federation, Poland, Hungary, Lithuania, Estonia, the Czech Republic, Bulgaria, Croatia, Greece, Belgium, the Netherlands, Germany, France, and the United Kingdom. That was for the largest of the Avandia clinical trials. But there have been scores of others, all seeking to prove that the drug is safe and effective.”

The F.D.A. has also lagged behind in declaring Avandia unsafe once the dangers were well known:

“In 2009 the Institute for Safe Medication Practices, a Pennsylvania-based nonprofit group that monitors the prescription-drug field, linked the deaths of 1,354 people to Avandia, based on reports filed with the F.D.A. Studies also concluded that people taking the drug had an increased risk of developing heart disease, one of the very conditions that doctors treating diabetics hope to forestall…

As always, the F.D.A. was late to the party. In 2008 the American Diabetes Association and the European Association for the Study of Diabetes had warned against using Avandia. The Saudi Arabian drug-regulatory agency yanked it from the market, and the Indian government asked Glaxo to halt 19 of its Avandia trials in that country. In September 2010 the European Medicines Agency pulled Avandia from the shelves all across Europe. The F.D.A. still could not bring itself to take decisive action

This even though the F.D.A. knew that Glaxo had withheld critical safety information concerning the increased risk of heart attacks, and the F.D.A. itself had estimated that the drug had caused more than 83,000 heart attacks between 1999 and 2007. The agency settled for imposing new restrictions on the availability of the drug in the United States.”

Click here to read more of the Deadly Medicine article from Vanity Fair.

Click here for more information Avandia, Avandia heart risks or about The Brandi Law Firm Avandia Lawyers.

For decades, the Brandi Law Firm has represented victims of defective pharmaceutical drugs and medical devices when their use has been shown to be unreasonably dangerous to users.  One similarity in all of these cases it that the adverse affects of these drugs was found after FDA approval through a high incidence of side effects.

There are now reports that the FDA is approving fewer new drugs “spurred by an ‘increased conservatism’ on safety issues” by the FDA.

However, at the Brandi Law Firm, we believe that safety of drugs and medical devices should be of the utmost importance when potentially approving a drug for sale in the United States.

Dalkon Shield – the Dalkon Shield was a birth control intrauterine device (IUD) marketed in the 1970s which rendered high percentages of women infertile due to a defect in its design.  The Brandi Law Firm helped secure settlements for over 300 women affected by this product and Thomas Brandi was appointed to serve on behalf of plaintiffs in Dalkon Shield class action matters in Virginia.

Fen-Phen – this was a weight loss drug prescribed heavily in the 1990s which was shown to increase heart and heart valve problems.  There, Mr. Brandi was Court appointed to serve on the plaintiffs’ Management Committee in the California Diet Drug Litigation where thousands of individuals were victimized by the diet pill.

Vioxx – this nonsteroidal anti-inflammatory drug (NSAID) was used for chronic aches and pains and marketed as a drug that didn’t adversely effect the gastrointestinal system.  In 2004, it was withdrawn from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.  Thomas Brandi was Court appointed to the Plaintiff’s Management Committee in the California  Vioxx Litigation where he tried one of the two Vioxx cases to go to verdict in California.

The Brandi Law Firm is actively representing people who have been adversely effected by the Avandia Diabetes Drug, DePuy Hip Recall, Fosamax Osteoporosis Drug, Yaz Birth Control, and Zicam Cold Drug.

Hopefully, in the future companies will better test their products prior to putting them to market and the FDA will continue set a high standard for safety.