Tag Archives: FDA

Government Oversight: Job Killer or Life Saver?

The news today of an unsafely compounded drug caught my eye, and not just because of the 5 dead (and counting). I apologize, up front, to you and your families, because I’m going to use this in a distinctly a-personal way. While I may say that my intentions are good, you know what they say about intentions and the road to hell…

What caught my eye in this story was ‘compounded drugs’ and ‘lack of oversight’.

Some years ago I worked with a number of compounding pharmacists.  Compounding, for those who may not know, is the art and science of mixing medications for specific use.

Remember, the Rx we see on prescription pads is short for recipe. I have seen pharmacists create compounds, using recipes the same way they would if making a Brunswick stew for the first time on the back counters of their store, compounds that generated dramatic improvement in ailing people when the medication wasn’t available commercially, or when they didn’t respond or couldn’t take those medications that were available.

Drug companies only make drugs as long as they are profitable, and much of that depends on whether they can be made generically or not. Most older drugs are the ones that can be made generically, and hence the ones that are most likely to be discontinued, in favor of newer, much more expensive drugs by profit oriented corporations.  Newer isn’t always better though.

Some folks are also allergic to the bases (liquids and powders) that are commonly used in medications. A compounding pharmacist can often make the same medicine in a different base to meet the needs of the sensitive and allergic.

From experience, I know that most compounding pharmacists have both an inclination towards the hands-on type of apothecary who has a broad range of knowledge and options to meet your health needs, but also the need of additional revenue streams.  Your hometown pharmacist got pinched by the big box stores just like the rest of small town America did, and compounding became an easy way to differentiate and add to the bottom line.

Which brings us to the oversight part of the equation.

It’s one thing to use a recipe and mix a salve of bismuth and iodine and vitamin E for use on a bedsore that won’t heal; it’s one thing to make hypoallergenic pills that do not contain cornstarch. It’s quite another to mix liquids for injection or intravenous use.

The quick answer is, because it’s way too easy for a lethal dose of bacteria (or fungus, or virus) to contaminate the preparation. And when bacteria or fungus or virus gets a straight shot into the bloodstream the body tends to get what locals around here would call ‘low sick’. Professionals call it sepsis. People who get low sick tend not to walk away from it.

Hospitals are required, as in regulation, to have strict medication preparation protocols and procedures that are designed to make safe the meds that go through our IV’s and into our muscles or spinal cords or lungs. These are not stuffy, unnecessary, job killing regulations (actually they create jobs)… they are based on recognized, best safe practices that minimize the chances for contamination and life taking infection. Take it from one who has spent years in hospitals: few would survive a hospitalization if not for regulations such as these.

Retail pharmacies aren’t governed by those rules, primarily because there was no anticipation that a retail pharmacy would ever be mixing medications for injection or intra-venous use. The FDA is now trying to assert some control in the area and is receiving push back from both the industry and conservatives, who say the FDA has no jurisdiction in the matter.  The fact that the Food and Drug Administration can have no jurisdiction over a demonstrably lethal drug that is manufactured and sold in America is a testament to those who, so far unable to repeal, have successfully worked to marginalize the efforts of the FDA.

Our hometown pharmacist, from the comfort of his backroom desk, amidst the clutter of  dusty boxes holding merchandise yet to make the shelf, the same desk where he has his lunch most days and goes through his bills after closing, the well-worn desk that is also his compounding bench, his kitchen, his laboratory for creating that-which-can’t-be-found-elsewhere, the very bench where he’d compound whatever you needed, even if it was meant to be shot into your spine or mainlined into your heart.

Most people are going to cringe at that thought, and I believe that they should.

Like I said, it caught my eye because it gives us a clear example of one of the questions we need to answer in America today. That question is:

Do we accept  ‘job killing’ government regulation,


Do we accept ‘people killing’ free market practices?

… because that is indeed what we’re talking about here. It’s one or the other.

If compounding pharmacies, most of which are independent retail stores, have to put in industry standard laminar flow hoods, and are held to the same standards of safe preparation and monitoring as hospitals are held to with medications for injection or intravenous use, it will surely drive most of them out of the compounding business. It’s a low overhead revenue stream, as soon as you start adding equipment and monitoring procedures you quickly lose profitability. And you know how lawmakers are, it won’t just be the injectables they go after. Many compounded meds are taking the place of a Big Pharma product, and those lobbyists won’t miss the opportunity to shut it all down.

But if the government stands back and does nothing, in the laissez-faire sort of way preferred by those who scream about ‘job killing government regulation’, then more people will die unnecessary, preventable deaths from bad drugs sold by good people, albeit people with only profits in mind.

Like this years presidential election, there’s a distinct difference in choices here.

A number of  years ago I parted ways with a good job in a growing company over my objection to compounding home care IV medications in local pharmacy backrooms without adequate safety measures. In fairness, I should say “without what I was trained to consider to be adequate safety measures.” Individual pharmacists whom I worked with and respected had differing opinions. My belief that their opinions were clouded by dollar signs is beside the point.

At the time, I wasn’t willing to risk my professional ethics and personal morality just to beat a competitor to a market niche. Put yourself in the shoes of the responsible people at the company whose contaminated product has just resulted in five deaths across the country. Mightn’t that bother you… just a bit? Even if it made you rich?

Could you enjoy the wealth knowing that a handful of people died after using your product, one that you knowingly decided to risk a higher chance of impurity for a bigger profit margin? Would it keep you awake at night wondering who might have gotten to walk their daughter down the aisle, or who might have greeted their family’s first grandson into the world, if you had only followed best practice instead of just what’s legal, and not one penny more?

My personal belief is this… one of the stated purposes of our government (Preamble to the Constitution) is to ‘provide for the common defence and promote the general welfare’. Defence is usually assumed to be from a foreign power, but in this case, we the people need defence from industry in order to have any sense of welfare, general or not.

In a capitalistic free market, the watchword is caveat emptor, “let the buyer beware”. There are over 3,000 compounding pharmacies in the USA. Just 162, (not the one implicated in today’s news), meet the standards of the Compounding Pharmacy Accreditation Board, a private agency which establishes quality and safety practices. That means over 2,838 compounding pharmacies that do not: over 2,838 companies that do not meet contemporary quality and safety standards for the compounding of pharmaceutical medications designed for human use, yet they still sell what they make, to us, to use. And we buy it.  Now think about that for a second…

According to the FDA, the medication that resulted in 5 deaths was contaminated with a fungus. Over 17,000 doses were shipped to 23 states. (and some argue that health care doesn’t qualify as interstate commerce!) Nor is this the first time compounded medications have caused deaths across the country. Alabama and South Carolina have both lost citizens to bungled compounded medications.

Companies have shown that when it comes to protecting the public or the environment, they use actuarial formulas to derive cost benefit ratios. Whether it is cars with gas tanks that tend to explode or a drug that causes more than it’s share of heart attacks and strokes, they know the product liability cost if 5 people die, or 50, or 500, or 5000. Only when the cost to them, not to those who died or the cost to those families, but only when the cost to them exceeds their profits will they consider other alternatives. In short, our lives are their acceptable losses. They do not self-police, they do not self-restrict in matters of public safety. It’s not that they don’t do the “right” thing, but that they define “right” in terms of most profitable.

Which is why, when it comes to food, water, drugs, and a multitude of other items deemed necessary for life today, we as a society have said that we need protection of life and limb from those who would profit at any cost.

It is, after all, one of the defining purposes of our government. We should not let sloganeers change that.