A team of FDA inspectors is now headed to China to inspect the correct plant, as part of an effort to determine what caused a sudden spike in serious reactions to heparin.
More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous drop in blood pressure, breathing difficulties, and vomiting. Four patients who took the drug died.
Federal law does not require inspections of foreign drugmakers, although the agency will in most instances inspect before a new foreign drug or active drug ingredient is allowed in FDA-approved prescription medications. Such an inspection does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.
There are so many problems with the FDA at this point; it’s hard to know where to start. Their failure to protect American consumers include whammies like:
the approval of the antibiotic Ketek, despite the fact that the study was so fraught with fabricated data it led to arrests and prison terms
the deadly Vioxx debacle
antidepressants found to incite murderous and suicidal episodes
lead tainted toys
toxic pet food
And that’s barely scratching the surface of the scab that is the FDA.
This is not the first time the safety of heparin has surfaced in the news. Heparin is one of the drugs that, frequently enough, cause of severe harm or death due to medical error in infants and young children.
Children given adult doses of heparin will suffer life threatening internal bleeding. Such was the case of actor Dennis Quaid’s twin babies, for example, who were given 10,000 units instead of 10 units of heparin, at the Cedars Sinai Medical Center in Los Angeles, California, last November.
One of the root causes for their utter abandonment of public safety is that the majority of the FDA’s funding comes from the very companies that it is seeking to monitor and evaluate. It’s a classic case of the fox guarding the henhouse. The FDA has progressively morphed into a mere pawn and instrument of the drug industry, which has little to do with drug safety, and everything to do with maximizing profits.
They have a very sweet and mutually rewarding relationship with the drug industry and that is not likely to change anytime soon.
If you want to read one of the most fascinating interviews I’ve ever posted on this site, read the detailed expose by FDA whistle-blower Dr. David Graham, who works in the FDA and informed the nation about the Vioxx scandal. These candid remarks from one of the top insiders at the FDA provide amazing insights into just how scandalous the situation really is over there.
The only real solution isn't minor changes to the existing structure, but a complete reform of the FDA. As long as a significant portion of the FDA's budget is being funded by the very companies they are supposedly regulating, real change is virtually impossible.
But until then, please, don't risk your money or your life on a paradigm designed to profit from your ill health. Instead, switch to natural methods that will allow your body to heal itself without the need for the deadly drugs being pushed on you by the drug companies and the FDA.