A Matter of Trust? FDA,Pharmaceuticals, Medical Device Manufactures & Our Health

As I've spent time this last week looking into a publicized web site, FreeImplants.com, for safety issues on the personal front…  I have also found many product safety issues and questions that have arisen from getting breast implants.  As a consumer advocate for safe and affordable health care, the following information causes me great concern - as it should for you!

Stateside Dispatch states:

In one more example of lax federal agencies being empowered to block tougher state protection of consumers, the Supreme Court ruled yesterday that states are barred from protecting consumers from faulty medical devices, such as breast implants, if the Federal Food and Drug Administration (FDA) has already approved those devices.

These means that a federal agency like the FDA, politicized by a right-wing President and dominated by industry-funded advisors, can unilaterally override laws in all fifty states that hold companies liable for harm to consumers.  This, despite the fact that, as the New York Times described:

The Institute of Medicine, the Government Accountability Office and the FDA's own science board have all issued reports concluding that poor management and scientific inadequacies have made the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Subverting Pro-Consumer Laws: Because it is impossible for any agency to find all problems with products during the approval process, states have long held medical device makers liable for harm to consumers. However, in 2004, the Bush Administration retroactively reinterpreted the 1976 Medical Device Amendments law to preempt state damages against devices approved by the FDA. But as the sole Senate sponsor of that 1976 law, Sen. Edward Kennedy condemned that interpretation of a law meant to protect the public, not protect industry:

In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices. Congress obviously needs to correct the court's decision. Otherwise, FDA approval will become a green light for shoddy practices by manufacturers.

A Dangerous Trend: We are seeing a cascade of federal agency decisions, backed by federal courts, that are gutting state law protections for consumers and workers.  The central question, as the Drug and Device Law blog puts it so eloquently in an essay today, is “whether a high regulation, low litigation environment is as effective a method of ensuring the safety of the public…or if it’s a lousy way of ensuring safe medical devices.”

There is only one way to know - and that is the hard way.

It is very disturbing to me to know that our personal safety is being ignored. That our health is being influenced by billions in corporate dollars - spent yearly to influence agencies like the FDA. Finally that harm can be caused by part of an industry who only cares about their own bottom line with no recourse for their deliberate actions. 

The part that scares me about this even more is if the medical device industry is allowed this leeway, will the FDA allow the pharmaceutical industry to follow? (although we could not function without many of our medications and they make a huge difference in our survival…this is an industry that demands 18% profit at our expense….every other Top 500 corporation, makes a 6-7% profit. On top of this huge profit, they release products without regard to life and safety. As recently as Tuesday, Kim Dixon of ABC news reported: U.S. regulators have never inspected the Chinese plant that makes Baxter International's heparin, regulators disclosed a day after Baxter halted sales of some versions after four patients died and hundreds became ill. "Preparations are being made to perform an inspection as soon as possible," Food and Drug Administration spokeswoman Karen Riley said in an email.On Tuesday, the Food and Drug Administration reported that it received about 350 reports of health problems associated with Baxter's injectable heparin, a blood thinner, since the end of 2007. Millions of patients each year receive the product intravenously. The drug generates about $29 million in annual revenue for Baxter, less than 1 percent of the company's total revenue, Gardiner said (- Another problem with exporting our production sites over seas, lax business practices or both?)

So what is being said….is if this powerful, influential industry harms us - the consumer - that they are not responsible because they have been able to buy off the opinions of the FDA and are no longer responsible.  What other industry is not held liable for their products? Why is the pharmaceutical and medical industry given such leniency in their actions?  At the end of the day,I guess, it comes down to trust in the system. Is that asking too much?