The ACP Advocate Blog

by Bob Doherty

Wednesday, October 31, 2012

Who you gonna call when your health is in danger?

How is this for a Halloween metaphor?  When it comes to emergencies that threaten our health and safety, we all expect the federal government to come to the rescue, just like the fictional Ghostbusters (from the 1984 movie of the same name) were the ones to call if  you find yourself haunted by surly ghosts.

But today, I write about something that is truly scary, the actual and potential loss of life from two unfolding health crises, one caused by nature (Hurricane Sandy) and one by human negligence (a fungal meningitis outbreak caused by an unsafe compounding pharmacy

As much as ideologues on the right argue that the federal government can’t do anything right,  that we should just leave protecting our health to free markets—and only if absolute necessary, the states, never ever the feds-- these  disasters show us that there is no substitute for calling on the federal government for help.

Here’s the story.  When the towns of New Jersey and the streets and tunnels of lower Manhattan and Brooklyn and Staten Island were overrun by Sandy’s water, the officials of those states knew that they couldn’t depend only on their own resources to get through it.  Yes, the committed first responders from the local community, the police, firefighters, EMTs, doctors and nurses who came to rescue and care for their neighbors, were essential and deserve everyone's admiration and appreciation.   Local and state governments played essential roles in preparing for disaster and organizing relief in the aftermath.  But they rightly expected the federal government also to ride to the rescue, in the form of Obama administration and its Federal Emergency Management Agency (FEMA), to provide federal resources.  So maligned for its Katrina performance, FEMA is aware that this time it has to pass the test. And so far it has: New Jersey Governor Chris Christie, a champion of small government, declared that “The President has been outstanding in this and so have the folks at FEMA.”

Then there is the fungal meningitis outbreak that has led to 28 deaths, hundreds sickened, and potentially thousands of being at risk of illness or death.  This man-made public health disaster appears to be the result of unsanitary and unsafe practices by a compounding pharmacy, the New England Compounding Center (NECC) that is exempt from federal regulation but subject to state regulation.  The Massachusetts agency responsible for regulating compounding pharmacies operating in the state said that it “didn’t have the power they needed to keep tabs on NECC.”

So let’s get this straight: the FDA, the federal agency that we rely on to ensure that the prescription drugs that we put into our bodies under a doctor’s orders are safe and effective is barred by federal law from regulating the compounding pharmacies that mix those drugs, and the states by their own admission lack the power they need to keep tabs on them?  If there is every a case for the federal government to exercise its constitutional authority to regulate Interstate Commerce (the compounded drugs in question were sold and administered throughout the country), this should be it, yet Congress and federal courts instead has told the FDA to keep its nose out of the compounding pharmacy business? 

Sadly, this isn’t the first time people have died because regulation of compounding pharmacies was left left to under-funded state regulators with inadequate enforcement powers to protect us from unsafe compounded drugs.

In observing that our health would be better protected if the FDA was able to regulate compounding pharmacies just as it does drug manufacturers, and that we rely on the federal government to help state and local authorities out when confronted with life-threatening disasters, I am not arguing that all federal regulation is good and necessary or that the federal government always gets it right.  Nor am I arguing that there isn’t a role for market competition and state regulation.  But I am saying that there are some things that are so critical to our health—the safety of our drugs and our food, the availability of resources to help us when confronted by storms and earthquakes and pandemics and other terrifying things that can kill or sicken us on a massive scale, that there is no substitute for all levels of government--local, state and federal--working together to help the common good.  The libertarian/conservative argument that the federal government should just get out of the way and let state and local governments and the private sector go it alone just doesn't hold water. Just ask the people who lost their homes in New York and New Jersey, or the families of loved ones who lost their lives because the FDA isn't allowed to regulate the safety of compounded drugs and the states aren't up to the job.

And although not as immediate or as readily seen on TV, I would add lack of access to health insurance to the list of health crises that require a national response.  We know from the Institute of Medicine and Urban Institute that lack of health insurance kills tens of thousands annually, far more than have died from fungal meningitis outbreak of from Hurricane Sandy.  We know that leaving the problem to the states to solve doesn’t work—if it did, we wouldn’t have states like Texas where one out of five people are without health insurance, while other states (most notably, Massachusetts) manage to cover almost everyone.  If it is true that we need the federal government to protect us from loss of life due to unsafe drugs no matter where in the U.S. we live or where the drugs were mixed or manufactured, shouldn’t we also be protected from loss of life due to lack of access to health insurance, no matter where we live?  And if we recognize that states can’t go it alone when it comes to stemming loss of life from natural disasters,  shouldn’t we also recognize that states can’t go it alone when it comes to ensuring that we all have access to health insurance, no matter where we live?

The message from Hurricane Sandy and the fungal meningitis outbreak is that we are all in it together.  We are safest when Washington partners with state and local governments and the private sector to protect public health and safety.  But only the federal government has the reach and resources and ability to organize a national response to national crises, whether it is responding to life-threatening national disasters or ensuring that our prescriptions are safe or guaranteeing that all Americans have access to health insurance.

Today’s questions:  So who you gonna call to help protect the public from human- and natural disasters that threaten lives and safety on a grand scale?  Only your state and local officials?  Your neighbors?  The business community? The federal government?  How about all of the above?

2 Comments :

Blogger Thomas Roesel said...

Dear Mr. Doherty,
There is a petition to request greater regulation of drug compounding facilities on the ”We the People” WhiteHouse.gov website. Compounding facilities need greater regulation to meet the medical standards that warrant Americans’ trust in healthcare.
You can view and sign the petition here (you may have to cut and paste in your browser):
http://wh.gov/kyfg
I hope you can also support this endeavor by mentioning it in your blog.

Sincerely,

Thomas Roesel MD, PhD, FACP

November 2, 2012 at 7:58 AM  
Blogger Thomas Roesel said...


Dear Mr. Doherty,
There is a petition to request greater regulation of drug compounding facilities on the ”We the People” WhiteHouse.gov website. Compounding facilities need greater regulation to meet the medical standards that warrant Americans’ trust in healthcare.
You can view and sign the petition here (you may have to cut and paste in your browser):
http://wh.gov/kyfg
I hope you can also support this endeavor by mentioning it in your blog.

Sincerely,

Thomas Roesel MD, PhD, FACP

November 2, 2012 at 8:00 AM  

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About the Author

Bob Doherty is Senior Vice President, American College of Physicians Government Affairs and Public Policy; Author of the ACP Advocate Blog

Email Bob Doherty: TheACPAdvocateblog@acponline.org.

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