Fatalities in the GOP War on Regulation

Meningits OutbreakFederal investigators close off access to the offices of the New England Compounding Center in Framingham, Massachusetts, October 16, 2012. Criminal investigators from the FDA were on site at the center on Tuesday in the first public indication that the government was preparing a criminal case against the company linked to a deadly outbreak of meningitis. (Photo: Barry Chin / Boston Globe)More Americans than died in the attacks on the World Trade Center die every year from contaminated medicine, food, air and water. Yet the GOP argues we cannot afford the promulgation and enforcement of the regulations that would save these lives.

I doubt Lilian Cary, 67, would be voting for Mitt Romney or any Republican this year. Actually, Lilian won’t be voting for anyone next week, because she died of meningitis, weeks after being injected with steroids for back pain. She is one of 25 people so far to have died from contaminated vials of epidural steroids. Her husband was also given those injections at the same clinic and could be facing a similar fate. As of late October, 338 people have been stricken by infection. In all, over 14,000 people have been injected with these contaminated steroids. There will undoubtedly be more illnesses and deaths before this mass tragedy is over.

The tainted vials were made by a pharmacy, New England Compounding Center (NECC). A deadly black fungus, Exserohilum, found in the vials was also found throughout the facility. “The entire pharmacy was an incubator of bacteria and fungus. The pharmacy knew this through monitoring results, and chose to do nothing,” said former FDA officer Sarah Sellers who left the agency in 2008 after unsuccessfully pushing it to increase regulation of compounding pharmacies. Employees knew about the unsterile conditions and violated established protocols, but the pharmacy chose to do nothing about it. Inspectors found multiple breaks in sterile techniques, including that employees had turned off the air conditioning at night to save the company money, undermining the conditions needed to prevent growth of contaminating organisms. Every drug the company made is now suspect.

Drug manufacturing companies such as NECC, prepare medications for clinics and doctors largely outside federal control. The FDA says that the law does not give it adequate authority to establish oversight, leaving regulation largely to the states. In my state, there is exactly zero oversight of this kind of product.

In my speciality, anesthesiology, it isn’t just contaminated drugs; there’s also a shortage of critical drugs. For the last several years, anesthesiologists have had to resort to suboptimal drug selection because some of our most important drugs have simply been unavailable. It seems that the free market doesn’t compel drug companies to make drugs if they don’t want to, or don’t find it profitable, or they can create artificial shortages to drive up prices.

Welcome to a glimpse of Mitt Romney’s and the Republican’s Party’s Holy Grail for economic revival – a free market on steroids, and a war on regulation. Virtually all government regulatory functions are under attack. Drug manufacturing, food safety, environmental protections, health care, banking and financial regulations, work place safety, and non-discrimination protection have all been placed on the altar of the free market under the cloak of “freedom, job creation” or the discipline and joy of “personal responsibility.”

Mitt Romney types can say that NECC will probably go out of business and in that respect it affirms that the free market works. But in this case – and so many others – the road to free market vindication is littered with dead bodies, lost jobs, lost life savings, and widespread suffering. Lilian Cary and the other NECC victims paid the ultimate price for poor regulations. I suppose in a sick way you could rationalize that even this is a manifestation of how well the free market works, like the “free market” of the Serengeti – the weak and the unlucky fall victim to predators in the jungle of corporate negligence and profiteering. And who could dispute that weak regulation has helped NECC create jobs – although at the morgue.

While the Republican’s wage an overt war on regulation, they also wage a covert war by demanding budget cuts to virtually all regulatory agencies, further neutering their ability to function. With the GOP demand for budget austerity, first on their list of things to cut is “discretionary spending,” which, among other things, means spending on enforcing regulations.

For example, even though President Obama signed the Food Safety Modernization Act into law – giving the FDA wider power to prevent food-borne illness outbreaks – the number of Americans who became sick or died because of contaminated food increased 44% over the last two years, according to a new report from the US Public Interest Research Group. But the FDA remains unable to implement the reforms because of Republican refusal to fund them.

Typical of the Republican thought process is this statement last year from Rep. Jack Kingston (R-GA): “The food supply in America is very safe because the private sector self-polices, because they have the highest motivation. They don’t want to be sued; they don’t want to go broke. They want their customers to be healthy and happy.”

This is how wildly successful this self policing strategy is: 76 million illnesses occur annually from contaminated food, with 128,000 requiring hospitalization and 3,000 people dying – every year – as many as died in the terrorist attacks at the World Trade Center (remember contaminated spinach, peanut butter, hamburger, and cantaloupes?). We have spent trillions of dollars on the “War on Terror,” the wars in Iraq and Afghanistan, homeland security, and Mitt Romney wants the sky to be the limit on even more defense spending, yet spending a few million to prevent contaminated food – which kills far more people – is something that the entire Republican Party just can’t tolerate.

Every five years, the Clean Air Act requires the EPA to revise national air quality standards to reflect current science. Current science indicates that existing standards are not strict enough and that standards 25% stricter would save about 36,000 lives – over ten times the number of deaths on 9/11 – every year (1). You have a far greater likelihood of dying from air pollution than you do from a terrorist attack. But Mitt Romney and the Republicans will not let up on the idea that clean air and clean water are killing jobs and the big polluters can’t afford it. Voting for them this fall means you will be voting to gut the Clean Air Act and the EPA’s budget, and that of the FDA, the SEC, and virtually every federal regulatory agency whose job it is to protect our citizens. For the Republicans, deregulation has such mythical power they would even have us be fooled by Wall Street into letting them police themselves again.

In the last few years, millions of Americans have lost their financial nest egg, the equity in their home, their job, health or even their lives because of the greed and excesses of business. And the Republicans would have you believe that somehow you are better off for it. In the immortal words mangled by George W. Bush, “Fool us once, shame on them, fool us twice, shame on us.”

Lilian Cary was fooled into thinking her government was looking out for her. It wasn’t. And if Romney and the Republicans fool Americans into voting for their war on regulation, we will have become a ship of fools indeed.


1. Report by the American Lung Association, Earthjustice, and Clean Air Task Force -How the EPA can save lives by cleaning up fine particle pollution. 2011.